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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Zoe Medical Incorporated: Vital Signs Monitors Recalled Due to Inadequate Battery Warning Labels

Agency Publication Date: September 10, 2024
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Summary

Zoe Medical Incorporated is recalling 7,935 Spacelabs Ultraview DM3 and DM4 Vital Signs Monitors because the product labeling does not provide enough warning about the risks of using damaged batteries or those that have exceeded their service life. This recall affects various monitor models including the 91330 (DM3) and 91331 (DM4) series, which were distributed across various healthcare settings. If the batteries in these monitors are not properly maintained or replaced when damaged, the device could fail unexpectedly or cause a safety hazard.

Risk

The lack of adequate warnings may lead users to continue using damaged or expired batteries, which can result in the monitor losing power during critical patient monitoring or, in severe cases, cause battery overheating or leakage.

What You Should Do

  1. Identify if you have the Spacelabs Ultraview DM3 (Model 91330) or DM4 (Model 91331) monitors by checking the model and serial numbers on the device label.
  2. For DM3 monitors (Model 91330), check for serial numbers up to FFD8292. This includes variations -M (UDI 00851920007002), -MT (UDI 00851920007019), -N (UDI 00851920007026), and -NT (UDI 00851920007033).
  3. For DM4 monitors (Model 91331), check for serial numbers up to GFD10486. This includes variations -M (00851920007347), -MF (00851920007354), -N (00851920007309), -NF (00851920007316), -MW (00851920007361), -MFW (00851920007378), -NW (00851920007323), and -NFW (00851920007330).
  4. Inspect all monitor batteries for physical damage, swelling, or leaks and ensure they are within their intended use life.
  5. Contact your healthcare provider or Zoe Medical Incorporated at 460 Boston St, Topsfield, MA for updated labeling and instructions on battery safety and maintenance.
  6. Contact the FDA for additional questions at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Labeling update and safety instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Spacelabs Ultraview DM3 Vital Signs Monitor (Model 91330)
Model / REF:
91330
91330-M
91330-MT
91330-N
91330-NT
UPC Codes:
00851920007002
00851920007019
00851920007026
00851920007033
Lot Numbers:
Serial numbers up to FFD8292
Product: Spacelabs Ultraview DM4 Vital Signs Monitor (Model 91331)
Model / REF:
91331-M
91331-MF
91331-N
91331-NF
91331-MW
91331-MFW
91331-NW
91331-NFW
UPC Codes:
00851920007347
00851920007354
00851920007309
00851920007316
00851920007361
00851920007378
00851920007323
00851920007330
Lot Numbers:
Serial numbers up to GFD10486

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95160
Status: Active
Manufacturer: Zoe Medical Incorporated
Sold By: Zoe Medical Incorporated; Healthcare facilities
Manufactured In: United States
Units Affected: 2 products (6429 units; 1506 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.