Welch Allyn Q-Stress and XScribe Diagnostic Devices Recalled for Safety Standard Deficiency
Welch Allyn is recalling Q-Stress and XScribe diagnostic devices because they may not meet specific 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, which typically corresponds to a High severity score (3) when no specific injuries or hospitalizations are reported in the source text, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling 78,521 units of Q-Stress and XScribe diagnostic devices. These devices are used for real-time ECG display, heart rate measurement, ST analysis, and ventricular ectopic beat detection. The recall affects model numbers QS-6XX-XXXXX, XSCRIBE-5XX-XXXXX, and XSCRIBE-6XX-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 is a Class II recall, indicating a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote.
The devices were distributed nationwide in the United States, including all 50 states, the District of Columbia, Puerto Rico, and Ontario, Canada. Users of these devices should contact Welch Allyn for further instructions on the recall and potential replacements or repairs.
The recalled product
- Product
- Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
- 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 (3)
- Model Numbers: QS-6XX-XXXXX
- XSCRIBE-5XX-XXXXX
- XSCRIBE-6XX-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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