medical Class II Updated 2020-05-06

WELCH ALLYN, INC/MORTARA recalls X12+ and patient cable for the X12+ Telemeter with the follo

Recalled Product

X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.

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: X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, 9293-034-50
View official government recall

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