Device product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Z-3098-2024
Product summary
- Event
- Event 95160
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6429 units
- Official record key
device-enforcement:Z-3098-2024
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. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330-M; UDI-DI 00851920007002; all serial numbers up to FFD8292 Model No. 91330-MT; UDI-DI 00851920007019; all serial numbers up to FFD8292 Model No. 91330-N; UDI-DI 00851920007026; all serial numbers up to FFD8292 Model No. 91330-NT; UDI-DI 00851920007033; all serial numbers up to FFD8292
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.