FDA (Devices) recall action 85297
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Welch Allyn is recalling ELI PC Service software because it may not meet defibrillation withstand safety requirements for medical electrical equipment.
Welch Allyn is recalling T12 wireless ECG devices because they may not meet defibrillation withstand safety requirements.
Welch Allyn is recalling S4 Wireless Telemeters and patient cables because they may not meet defibrillation withstand safety standards.
Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.
Welch Allyn is recalling 78,521 Q-Tel RMS systems because they may not meet defibrillation withstand safety requirements.
Welch Allyn is recalling Q-Stress and XScribe diagnostic devices because they may not meet specific defibrillation withstand safety requirements.
Welch Allyn is recalling 78,521 lead diagnostic electrocardiographs because they may not meet defibrillation withstand requirements.
Welch Allyn is recalling 78,521 Surveyor S12 and S19 bedside monitors and patient cables because they may not meet defibrillation withstand safety requirements.
Welch Allyn is recalling 78,521 ECG lead sets because they may not meet defibrillation withstand safety requirements.
Welch Allyn is recalling H12+ Holter Recorders and patient cables because they may not meet defibrillation withstand requirements.