Device product
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Z-3099-2024
Product summary
- Event
- Event 95160
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1506 units
- Official record key
device-enforcement:Z-3099-2024
Official wording
Reason: This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
Code information: 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 pattern: awaiting additional details
Derived failure modes
-
Unknown
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.