Welch Allyn, Inc. 901060 (REF 68NXTX-R)Recalls & reported problems
Welch Allyn, Inc. · REFURB COMP VSM6800 SPN ST RADIO · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Mar 24, 2025Class IIOpen, Classified
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Z-1558-2025 · Root cause: Process design · Recall details · FDA record ↗
- Mar 21, 2025Class IIOpen, Classified
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1564-2025 · Root cause: Device Design · Recall details · FDA record ↗
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- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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