FDA Device recall Z-3099-2024

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

FDA Device
Class II
ongoing
Published 2024-09-18

On 2024-09-18 the FDA classified a Class II recall of Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331 by Zoe Medical, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3099-2024
Classification	Class II
Status	ongoing
Initiated	2024-08-13
Published	2024-09-18
Last updated	2026-09-13 11:57 UTC
Company	Zoe Medical
Distribution	n/a

Product

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

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.

Identifiers

code_info	Model No. 91331-M; UDI-DI 00851920007347; all serial numbers up to GFD10486 Model No. 91331-MF; UDI-DI 00851920007354;… 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

code_info

Model No. 91331-M; UDI-DI 00851920007347; all serial numbers up to GFD10486 Model No. 91331-MF; UDI-DI 00851920007354;…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3099-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.