Z-3098-2024 Class II Ongoing
FDA device recall Z-3098-2024 was initiated by Zoe Medical Incorporated on August 13, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 6429 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- August 13, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6429 units
Product Description
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Reason for Recall
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.
Distribution Pattern
awaiting additional details
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