Recall Z-1816-2020— WELCH ALLYN, INC/MORTARA

Name: FDA recall Z-1816-2020
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: K173765. 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.. 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

K173765 — Surveyor Patient MonitorMortara Instrument, Inc.·cleared 2018-09-04

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

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.

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.