Zoe Medical Incorporated: Medical Device Recall in 2024 - (Recall #: Z-3099-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 13, 2024

Date Posted: September 18, 2024

Recall Number: Z-3099-2024

Event ID: 95160

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.

Status: Ongoing

Product Quantity: 1506 units

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

Voluntary or Mandated:

Voluntary: Firm initiated