The Recall Desk
ModerateFDA (Devices)·Z-3098-2024·Announced 2024-09-18

Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall for a labeling deficiency with no reported illnesses or injuries. The hazard involves inadequate warnings about battery risks rather than confirmed incidents. Per the severity rubric, a Class II recall without hospitalization reports scores as Moderate (2).

Plain-English summary

Zoe Medical Incorporated is recalling 6,429 units of the Spacelabs Ultraview DM3 Vital Signs Monitor (Model 91330 and variations -M, -MT, -N, -NT, with serial numbers up to FFD8292). The FDA has classified this as a Class II recall because the product labeling does not adequately warn about the risks from using damaged batteries or batteries past their intended use life.

All product variations with serial numbers up to FFD8292 are included in this recall.

Users of these monitors should be aware of this labeling issue and ensure that any damaged or expired batteries are not used with the device.

The recalled product

Product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Manufacturer
Zoe Medical Incorporated
Category
Medical Device — Vital Signs Monitor
Hazard
Affected units
6,429

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Model No. 91330
  • no UDI-DI (distributed prior to UDI regulation)
  • all serial numbers up to FFD8292 Model No. 91330
  • 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

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Zoe Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Zoe Medical Incorporated

See all →

Same hazard · battery failure

See all →