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Recall Observatory FDA recall evidence

Device product

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

Z-3099-2024

August 13, 2024

Class II

Product summary

Firm
Zoe Medical Incorporated
Event
Event 95160
Status
Ongoing
Classification
Class II
Quantity
1506 units
Official record key
device-enforcement:Z-3099-2024

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. 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

Distribution pattern: awaiting additional details

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.