Zoe Medical Incorporated: Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

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: 1506 units Lot/code info: 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

UPC codes

00851920007347, 00851920007354, 00851920007309, 00851920007316, 00851920007361, 00851920007378, 00851920007323, 00851920007330

Source

Official record: FDA (Device enforcement) ↗

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