Skip to content
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 17 of 3592

Mode Product Rule Evidence excerpt
Device software or design IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 reason.device_software_design · v1.0.0 firmware issue
Device software or design ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 reason.device_software_design · v1.0.0 software and a component failure
Device software or design ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software reason.device_software_design · v1.0.0 software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may
Device software or design Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 reason.device_software_design · v1.0.0 cybersecurity vulnerabilities
Device software or design ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ClearCanvas RIS/PACS reason.device_software_design · v1.0.0 software defect
Device software or design ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901 reason.device_software_design · v1.0.0 does not correspond to the intended design
Device software or design ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068 reason.device_software_design · v1.0.0 does not correspond to the intended design

Field note

Send feedback

We'll only use this to respond to your feedback.