Recall Z-1814-2020— WELCH ALLYN, INC/MORTARA

Name: FDA recall Z-1814-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-18

Class II · Terminated

Class II FDA medical device recall by WELCH ALLYN, INC/MORTARA, initiated 2020-03-18, terminated 2026-02-09. It names one FDA 510(k) clearance: K974149. 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.. Reason: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment..

Recalling firm: WELCH ALLYN, INC/MORTARA
Classification: Class II
Status: Terminated
Initiated: 2020-03-18
Terminated: 2026-02-09
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K974149 — AMBULATORY X-12 TELEMETRY MODULEMortara Instrument, Inc.·cleared 1998-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.