FDA Medical Device Recalls (openFDA)
Ascom US, INC.: 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
- Recalling firm
- Ascom US, INC.
- Product
- Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
- Status
- Terminated
- Initiated
- 2015-12-10
- Posted
- not on file
- Terminated
- 2017-10-13
- 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.
- Root cause
- Software design
- Action
- On January 4, 2016 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 2016, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.
- Quantity
- 319
- Distribution
- 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.
- Lot, serial or model codes
- Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
- 510(k) numbers
- ["K111215"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 3008855170
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28