Spacelabs Ultraview DM4 Monitor Recalled for Inadequate Battery Safety Warnings
Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported deaths, injuries, or illnesses. The hazard is a labeling deficiency regarding battery risks. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3. A labeling deficiency on a critical patient monitoring device constitutes High severity.
Plain-English summary
Zoe Medical Incorporated is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor, Model 91331 and all variations. The affected units are identified by UDI-DI codes and include all serial numbers up to GFD10486.
The product labeling does not adequately warn about risks from using damaged batteries or batteries past their intended use life. This inadequate labeling prompted the FDA to classify this as a Class II recall.
Hospitals and healthcare facilities using this vital signs monitor should be aware of this recall. Proper battery maintenance and understanding battery risks are important for safe device operation.
The recalled product
- Product
- Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
- Manufacturer
- Zoe Medical Incorporated
- Hazard
- inadequate-warning
- battery-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Model No. 91331-M
- UDI-DI 00851920007347
- all serial numbers up to GFD10486 Model No. 91331-MF
- UDI-DI 00851920007354
- all serial numbers up to GFD10486 Model No. 91331-N
- UDI-DI 00851920007309
- all serial numbers up to GFD10486 Model No. 91331-NF
- UDI-DI 00851920007316
- all serial numbers up to GFD10486 Model No. 91331-MW
- UDI-DI 00851920007361
- all serial numbers up to GFD10486 Model No. 91331-MFW
- UDI-DI 00851920007378
- all serial numbers up to GFD10486 Model No. 91331-NW
- UDI-DI 00851920007323
- all serial numbers up to GFD10486 Model No. 91331-NFW
- UDI-DI 00851920007330
- all serial numbers up to GFD10486
Distribution
Distribution scope not specified by the agency.
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