May

2016

Cl II Ascom Mobile Monitoring Gateway

Company: Acusom US Inc.
Date of Enforcement Report 5/18/2016
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
Ascom US Inc, Morrisville, NC on 12/10/2015 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
319

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Ascom Mobile Monitoring Gateway

Amy Sellers

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