Recall Z-1484-2021— Welch Allyn Inc Mortara

Name: FDA recall Z-1484-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-31

Class II · Terminated

Class II FDA medical device recall by Welch Allyn Inc Mortara, initiated 2021-03-31, terminated 2024-08-16. It names one FDA 510(k) clearance: K173765. Product: Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.. Reason: Devices do not meet IEC 60601-2-27 requirements as labeled..

Recalling firm: Welch Allyn Inc Mortara
Classification: Class II
Status: Terminated
Initiated: 2021-03-31
Terminated: 2024-08-16
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 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Reason for recall

Devices do not meet IEC 60601-2-27 requirements as labeled.

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