Ascom Mobile Monitoring Gateway and Nurse Call Software Recall
Ascom US, INC. is recalling 319 units of Mobile Monitoring Gateway and Unite Connect for Nurse Call due to a software malfunction that prevents automatic message forwarding if the primary module fails.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a functional software failure that disrupts message forwarding, which fits the criteria for a moderate severity issue without reported harm.
Plain-English summary
Ascom US, INC. is recalling 319 units of Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). The recall is due to a software malfunction where the secondary module does not automatically take over messaging if the primary module fails after a software upgrade to one of the affected versions.
As a result of this defect, messages from GE Carescape/Nurse Call systems will not forward to handsets until the primary module is restored. The affected products were distributed in 25 U.S. states and 12 international countries, including Australia, Canada, and Germany.
Healthcare facilities should contact Ascom US, INC. for instructions on how to resolve the software issue. The source text does not specify a specific action for consumers, as these are medical devices used in professional settings.
The recalled product
- Product
- Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
- Manufacturer
- Ascom US, INC.
- Affected units
- 319
Distribution
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