Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1814-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2020-03-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1814-2020
Date of alert
2020-03-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
WELCH ALLYN, INC/MORTARA
Product category
device
Product type
Devices
Reported risk: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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