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Recall Observatory FDA recall evidence

Device product

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

Z-3098-2024

August 13, 2024

Class II

Product summary

Firm
Zoe Medical Incorporated
Event
Event 95160
Status
Ongoing
Classification
Class II
Quantity
6429 units
Official record key
device-enforcement:Z-3098-2024

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. 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

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.