Welch Allyn Q-Tel RMS System Recalled for Defibrillation Safety Non-Compliance
Welch Allyn is recalling 78,521 Q-Tel RMS systems because they may not meet defibrillation withstand safety 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 is classified as FDA Class II, and the hazard involves a medical device failing to meet safety standards for defibrillation withstand, which poses a risk of harm without reported injuries.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling 78,521 units of the Q-Tel RMS system, a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system. The recall is due to the possibility that the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
The affected products were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario, Canada. The specific model numbers are identified as X12PLUS-XXX-XXXXX.
Consumers and healthcare facilities should contact Welch Allyn for further instructions regarding the recall and potential replacement or repair of the affected units.
The recalled product
- Product
- Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
- 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 (1)
- Same as X12+ Model Number X12PLUS-XXX-XXXXX
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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