Zoe Medical Incorporated: Medical Device Recall in 2024 - (Recall #: Z-3098-2024)

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

Product Classification:

Class II

Date Initiated: August 13, 2024
Date Posted: September 18, 2024
Recall Number: Z-3098-2024
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: 6429 units
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

Voluntary or Mandated:

Voluntary: Firm initiated