medical Class II Updated 2020-05-06

WELCH ALLYN, INC/MORTARA recalls Surveyor S12/S19 and patient cable for the S12/S19 Bedside M

Recalled 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 applications.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Numbers: SUR12-XXX-XXXXX, SUR19-XXX-XXXXX, 9293-033-52, 9293-033-53.
View official government recall

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