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

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. — recall Z-1484-2021

U.S. FDA — Device Enforcement · United States · 2021-03-31 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1484-2021
Date of alert
2021-03-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Welch Allyn Inc Mortara
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
732094288926
Reported risk: Devices do not meet IEC 60601-2-27 requirements as labeled.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.