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Recall Observatory FDA recall evidence

Device product

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

Z-1638-2016

December 10, 2015

Class II

Product summary

Firm
Ascom US, INC.
Event
Event 73578
Status
Terminated
Classification
Class II
Quantity
319
Official record key
device-enforcement:Z-1638-2016

Official wording

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.

Code information: Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0

Distribution pattern: CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    malfunction of software