FDAMarch 18, 2020device

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 applications.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

What to do

FDA enforcement status: Terminated

Brands named

welch allyn inc mortarawelchwelch allyn

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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