Welch Allyn Surveyor S12 and S19 Patient Monitors Recalled for Defibrillation Safety
Welch Allyn is recalling 78,521 Surveyor S12 and S19 bedside monitors and patient cables 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 during emergency procedures, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Welch Allyn, Inc/Mortara is recalling 78,521 units of Surveyor S12 and S19 bedside monitors and associated patient cables. The affected devices include specific patient cable models identified as PAT CBL 10WIRE AHA SNAP JSCREW and PAT CBL 10WIRE IEC SNAP JSCREW. The monitors are designed for continuous monitoring in stationary or portable applications.
The recall was initiated because the impacted products may not meet the Defibrillation Withstand requirements of the EN/IEC 60601-2-25 standard for Medical Electrical Equipment. This standard ensures that medical devices can safely withstand the electrical energy delivered during defibrillation procedures without causing harm to the patient or malfunctioning.
The affected units were distributed nationwide in the United States, including the District of Columbia, Puerto Rico, and Ontario, Canada. Consumers and healthcare facilities should identify affected units by checking the model numbers SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, or 9293-033-53. Users should contact Welch Allyn for instructions on how to proceed with the recall.
The recalled product
- Product
- Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE IEC SNAP JSCREW. The Surveyor S12 patient monitor is designed for continuous monitoring in either stationary or portable applica
- Manufacturer
- WELCH ALLYN, INC/MORTARA
- Category
- Medical Device — Patient Monitor
- 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 (4)
- Model Numbers: SUR12-XXX-XXXXX
- SUR19-XXX-XXXXX
- 9293-033-52
- 9293-033-53.
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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