Zoe Medical Incorporated: Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Hazard

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.

Details from the source

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: awaiting additional details Quantity: 6429 units Lot/code info: 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

UPC codes

00851920007002, 00851920007019, 00851920007026, 00851920007033

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.