Welch Allyn H12+ Holter Recorders Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling H12+ Holter Recorders and patient cables because they may not meet defibrillation withstand requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may not meet safety standards for defibrillation withstand, posing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling H12+ Holter Recorders and specific patient cables. The affected devices include the H12+ recorder and patient cables with device names PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, and PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery and a removable 24-hour compact flash card for data storage.
The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. This standard ensures that medical electrical equipment can withstand defibrillation without causing harm to the patient or operator.
A total of 78,521 units were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario. Affected model numbers include H12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, and 9293-026-51. Users should contact Welch Allyn for instructions on how to resolve the issue.
The recalled product
- Product
- H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkali
- Manufacturer
- WELCH ALLYN, INC/MORTARA
- Affected units
- 78,521
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Numbers: H12PLUS-XXX-XXXXX
- 9293-017-50
- 9293-017-51
- 9293-026-50
- 9293-026-51.
Distribution
Part of a larger recall action
This product is one of 10 recalled by WELCH ALLYN, INC/MORTARA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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