Recall Z-1638-2016— Ascom US, INC.

Name: FDA recall Z-1638-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-10

Class II · Terminated

Class II FDA medical device recall by Ascom US, INC., initiated 2015-12-10, terminated 2017-10-13. It names one FDA 510(k) clearance: K111215. Product: Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).. 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: Ascom US, INC.
Classification: Class II
Status: Terminated
Initiated: 2015-12-10
Terminated: 2017-10-13
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K111215 — ASCOM MOBILE MONITORING GATEWAY (MMG)Ascom (Sweden) AB·cleared 2011-07-05

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

Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).

Reason for recall

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.

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