Ascom Mobile Monitoring Gateway — Class II medical device recall Z-1638-2016
Terminated recall by Ascom US, INC., reported 2016-05-18, distributed in CA, CT, FL, HI, IA, ID, IL, IN…. Due to a malfunction of software, the secondary module will not automatically take over messaging if the prima
| Recall number | Z-1638-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascom US, INC., Morrisville, NC, United States |
| Recall initiated | 2015-12-10 |
| Classified | 2016-05-10 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-10-13 |
| Distributed | CA, CT, FL, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI |
| Countries outside the US | AE, AT, AU, BE, CA, CH, DE, FR, NL, PL, QA, SE |
| Quantity | 319 |
| Reason classes | device malfunction, software |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1638-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.