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Recall Observatory FDA recall evidence

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Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1548 of 1581

Evidence Product Join Root cause
device-recall:cfres:138017 Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes Official recall number · Z-2155-2015 Process control
device-recall:cfres:138126 Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Official recall number · Z-2158-2015 Reprocessing Controls
device-recall:cfres:138163 Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Official recall number · Z-2181-2015 Reprocessing Controls
device-recall:cfres:138770 GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Official recall number · Z-2195-2015 Software design
device-recall:cfres:138132 Fiber Stripper, 150¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Official recall number · Z-2164-2015 Reprocessing Controls
device-recall:cfres:138575 Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Official recall number · Z-2131-2015 Software design
device-recall:cfres:138195 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. Official recall number · Z-2210-2015 Labeling mix-ups
device-recall:cfres:136169 Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Official recall number · Z-2254-2015 Software change control
device-recall:cfres:138124 Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Official recall number · Z-2156-2015 Reprocessing Controls
device-recall:cfres:138754 Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n. Official recall number · Z-2200-2015 Software design
device-recall:cfres:137724 ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Official recall number · Z-2140-2015 Device Design
device-recall:cfres:138105 Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument. Official recall number · Z-2190-2015 Process control
device-recall:cfres:138382 Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic Official recall number · Z-2232-2015 Other
device-recall:cfres:137882 Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems Official recall number · Z-2205-2015 Mixed-up of materials/components
device-recall:cfres:138160 Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Official recall number · Z-2178-2015 Reprocessing Controls
device-recall:cfres:137979 Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Official recall number · Z-2397-2015 Nonconforming Material/Component
device-recall:cfres:138585 Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100. Official recall number · Z-2362-2015 Process control
device-recall:cfres:137977 Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Official recall number · Z-2396-2015 Nonconforming Material/Component
device-recall:cfres:137968 Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities. Official recall number · Z-2393-2015 Nonconforming Material/Component
device-recall:cfres:138818 RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Official recall number · Z-2390-2015 Device Design
device-recall:cfres:139223 AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits. Official recall number · Z-2380-2015 Process control
device-recall:cfres:137669 Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Official recall number · Z-1782-2015 Nonconforming Material/Component
device-recall:cfres:137172 Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods. Official recall number · Z-1713-2015 Under Investigation by firm
device-recall:cfres:136590 EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes. Official recall number · Z-1714-2015 Nonconforming Material/Component
device-recall:cfres:137146 ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation. Official recall number · Z-1819-2015 Device Design

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