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Recall Observatory FDA recall evidence

Core noun

Failure mode assignments

Deterministic labels derived from preserved recall-reason text.

Indexed record set

89,789 assignments

Page 28 of 3592

Mode Product Rule Evidence excerpt
Device software or design Por fullct fem st 16x200mm, Sterile, reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Por fullct fem st 18x200mm, Sterile, reason.device_software_design · v1.0.0 design verification test failures
Device software or design Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants reason.device_software_design · v1.0.0 design verification test failures
Device software or design Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure reason.device_software_design · v1.0.0 software may show an incorrect
Device software or design IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. reason.device_software_design · v1.0.0 software defect
Device software or design Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST FNSTRD HIP 52HDX152ST FNSTRD HIP 53HDX152ST FNSTRD HIP 54HDX152ST FNSTRD HIP 55HDX152ST FNSTRD HIP 57HDX152ST FNSTRD HIP 60HDX152ST FNSTRD HIP 63HDX152ST FNSTRD HIP 38HDX140ST FNSTRD HIP 40HDX140ST FNSTRD HIP 41HDX140ST FNSTRD HIP 42HDX140ST FNSTRD HIP 43HDX140ST FNSTRD HIP 44HDX140ST FNSTRD HIP 45HDX152ST FNSTRD HIP 46HDX152ST FNSTRD HIP 47HDX152ST FNSTRD HIP 48HDX152ST FNSTRD HIP 49HDX152ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST HIP PROS 38HDX105ST HIP PROS 40HDX105ST HIP PROS 41HDX105ST HIP PROS 42HDX105ST HIP PROS 43HDX105ST HIP PROS 44HDX105ST HIP PROS 45HDX105ST HIP PROS 46HDX105ST HIP PROS 47HDX105ST HIP PROS 48HDX105ST HIP PROS 49HDX105ST HIP PROS 50HDX105ST HIP PROS 51HDX105ST HIP PROS 52HDX105ST HIP PROS 53HDX105ST HIP PROS 54HDX105ST HIP PROS 55HDX105ST HIP PROS 57HDX105ST HIP PROS 60HDX105ST HIP PROS 63HDX105ST FNSTRD HIP 38HDX165ST FNSTRD HIP 40DX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 42HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 45HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 47HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 50HDX191ST FNSTRD HIP 51HDX191ST FNSTRD HIP 52HDX191ST FNSTRD HIP 53HDX191ST FNSTRD HIP 54HDX191ST FNSTRD HIP 55HDX191ST FNSTRD HIP 57HDX191ST FNSTRD HIP 60HDX191ST FNSTRD HIP 63HDX191ST FNSTRD HIP 38HDX165ST FNSTRD HIP 41HDX165ST FNSTRD HIP 43HDX165ST FNSTRD HIP 44HDX165ST FNSTRD HIP 46HDX165ST FNSTRD HIP 48HDX165ST FNSTRD HIP 49HDX165ST FNSTRD HIP 51HDX165ST HIP PROS 38HDX127ST HIP PROS 40HDX127ST HIP PROS 41HDX127ST HIP PROS 42HDX127ST HIP PROS 43HDX127ST HIP PROS 44HDX127ST HIP PROS 45HDX140ST HIP PROS 46HDX140ST HIP PROS 47HDX140ST HIP PROS 48HDX140ST HIP PROS 49HDX140ST HIP PROS 50HDX152ST HIP PROS 51HDX152ST HIP PROS 52HDX152ST HIP PROS 53HDX152ST HIP PROS 54HDX152ST HIP PROS 55HDX152ST HIP PROS 57HDX152ST HIP PROS 60HDX152ST HIP PROS 63HDX152ST HIP PROS 38HDX165ST HIP PROS 40HDX165ST HIP PROS 41HDX165ST HIP PROS 42HDX165ST HIP PROS 43HDX165ST HIP PROS 44HDX165ST HIP PROS 45HDX165ST HIP PROS 46HDX165ST HIP PROS 47HDX165ST HIP PROS 48HDX165ST HIP PROS 49HDX165ST HIP PROS 50HDX191ST HIP PROS 51HDX191ST HIP PROS 52HDX191ST HIP PROS 53HDX191ST HIP PROS 54HDX191ST HIP PROS 55HDX191ST HIP PROS 57HDX191ST HIP PROS 60HDX191ST HIP PROS 63HDX191ST reason.device_software_design · v1.0.0 design verification test failures
Device software or design ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844  ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. reason.device_software_design · v1.0.0 software versions 1.1.04, display an IMG_15 error
Device software or design Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments. reason.device_software_design · v1.0.0 software correction to address the issue
Device software or design FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM FEM IM NAIL 13MMDX40CM FEM IM NAIL 14MMDX40CM FEM IM NAIL 15MMDX40CM FEM IM NAIL 11MMDX42CM FEM IM NAIL 12MMDX42CM FEM IM NAIL 13MMDX42CM FEM IM NAIL 14MMDX42CM FEM IM NAIL 15MMDX42CM FEM IM NAIL 11MMDX44CM FEM IM NAIL 12MMDX44CM FEM IM NAIL 13MMDX44CM FEM IM NAIL 14MMDX44CM FEM IM NAIL 10MMDX46CM FEM IM NAIL 11MMDX46CM FEM IM NAIL 12MMDX46CM FEM IM NAIL 13MMDX46CM FEM IM NAIL 14MMDX46CM FEM IM NAIL 10MMDX48CM FEM IM NAIL 11MMDX48CM FEM IM NAIL 12MMDX48CM FEM IM NAIL 13MMDX48CM FEM IM NAIL 14MMDX48CM FEM IM NAIL 13MMDX50CM FEM IM NAIL 14MMDX50CM reason.device_software_design · v1.0.0 design verification test failures
Device software or design Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories reason.device_software_design · v1.0.0 Software error
Device software or design Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes reason.device_software_design · v1.0.0 software error
Device software or design IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. reason.device_software_design · v1.0.0 software issues have been identified in the affected products. Problem
Device software or design eCare Coordinator Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. eCare Coordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only and is not to be used as a substitute for professional judgment of healthcare providers in diagnosing and treating patients. reason.device_software_design · v1.0.0 software defect
Device software or design Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively. reason.device_software_design · v1.0.0 Software defect
Device software or design Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135DX10H TUBE&SCP PLT 135DX12H TUBE&SCP PLT 135DX14H TUBE&SCP PLT 140DX8H TUBE&SCP PLT 140DX10H TUBE&SCP PLT 140DX12H TUBE&SCP PLT 140DX14H TUBE&SCP PLT 145DX8H TUBE&SCP PLT 145DX10H TUBE&SCP PLT 145DX12H TUBE&SCP PLT 145DX14H TUBE&SCP PLT 150DX6H TUBE&SCP PLT 150DX8H TUBE&SCP PLT 150DX10H TUBE&SCP PLT 150DX12H TUBE&SCP PLT 150DX14H VERSA-FX II SC TUBE PLT 90DX6H VERSA-FX II SC TUBE PLT 90DX8H VERSA-FXII SC TUBE PLT 90DX10H VERSA-FXII SC TUBE PLT 90DX12H VERSA-FXII SC TUBE PLT 90DX14H VERSA-FXII SC TUBE PLT 95DX6H VERSA-FXII SC TUBE PLT 95DX8H VERSA-FXII SC TUBE PLT 95DX10H VERSA-FXII SC TUBE PLT 95DX12H VERSA-FXII SC TUBE PLT 95DX14H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95D X 14HOLE VERSA-FX II STD TUBE 130DX8H VERSA-FX II STD TUBE 130DX10H VERSA-FX II STD TUBE 130DX12H VERSA-FX II STD TUBE 130DX14H VERSA-FX II STD TUBE 135DX8H VERSA-FX II STD TUBE 135DX10H VERSA-FX II STD TUBE 135DX12H VERSA-FX II STD TUBE 135DX14H VERSA-FX II STD TUBE 140DX8H VERSA-FX II STD TUBE 140DX10H VERSA-FX II STD TUBE 140DX12H VERSA-FX II STD TUBE 140DX14H VERSA-FX II STD TUBE 145DX8H VERSA-FX II STD TUBE 145DX10H VERSA-FX II STD TUBE 145DX12H VERSA-FX II STD TUBE 145DX14H VERSA-FX II STD TUBE 150DX8H VERSA-FX II STD TUBE 150DX10H VERSA-FX II STD TUBE 150DX12H VERSA-FX II STD TUBE 150DX14H VERSA-FX II KEYLESS TB 130DX8H VERSA-FX II KEYLESS TB 135DX8H VERSA-FX II KEYLESS TB 140DX8H VERSA-FX II KEYLESS TB 145DX8H VERSA-FX II KEYLESS TB 150DX8H VERSA-FX KEYLESS 90D X 8HOLE VERSA-FX KEYLESS 90D X 11HOLE VERSA-FX KEYLESS 95D X 8HOLE VERSA-FX KEYLESS 95D X 11HOLE VERSA-FX KEYLESS 95D X 14HOLE reason.device_software_design · v1.0.0 design verification test failures
Device software or design Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1 reason.device_software_design · v1.0.0 design verification test failures
Device software or design Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM reason.device_software_design · v1.0.0 design verification test failures
Device software or design Digital RID Plate Reader and Software Product Code: AD400 reason.device_software_design · v1.0.0 software will
Device software or design Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively. reason.device_software_design · v1.0.0 Software defect
Device software or design Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx reason.device_software_design · v1.0.0 software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can
Device software or design Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. reason.device_software_design · v1.0.0 Software error

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