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

Recall Z-1638-2016 — Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

U.S. FDA — Device Enforcement · United States · 2015-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1638-2016
Date of alert
2015-12-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ascom US, INC.
Product category
device
Product type
Devices
Reported risk: Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. Messages from GE Carescape/Nurse Call will not forward to handset until primary module is restored.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.

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