FDAFDA · Food and drugs·Recall number Z-3099-2024
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Published September 18, 2024 · Recall initiated: August 13, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zoe Medical Incorporated
- Distributor
- awaiting additional details
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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