Welch Allyn T12 Wireless ECG Devices Recalled for Defibrillation Safety
Welch Allyn is recalling T12 wireless ECG devices 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 involves a medical device that may fail to meet safety standards for defibrillation withstand, posing a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling 78,521 units of the T12 wireless electrocardiographic device. The product is used to acquire and transmit 12-lead ECG data while allowing patients to be ambulatory. The recall covers model numbers T12-XXX-XXXXX and T12S-XXX-XXXXX.
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 malfunctioning.
The devices were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario, Canada. Consumers and healthcare providers should contact Welch Allyn for further instructions on how to address the safety concern.
The recalled product
- Product
- T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.
- 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 (2)
- Model Numbers: T12-XXX-XXXXX
- T12S-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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