Zoe Medical recalls Spacelabs Ultraview DM4 Vital Signs Monitors with outdated battery warnings. All model variations and serial numbers up to GFD10486 are affected. This labeling issue may lead to risks from damaged or expired batteries.
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.
Zoe Medical is recalling Spacelabs Ultraview DM4 Vital Signs Monitors due to inadequate warnings about battery risks. Using these monitors with damaged or expired batteries could lead to safety issues. Affected units include all model variations and serial numbers up to GFD10486.
The monitor's labeling does not clearly warn about risks when batteries are damaged or have exceeded their intended use life. This could lead to potential safety issues if the batteries fail during use.
Users of Spacelabs Ultraview DM4 Vital Signs Monitors with model numbers 91331 and serial numbers up to GFD10486 are affected. Patients and caregivers using these monitors for medical monitoring are most at risk.
Check for model numbers 91331 with variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW. All serial numbers up to GFD10486 are affected. The product may have UDI-DI codes listed in the recall notice.
Review the monitor's battery labeling to ensure it provides warnings about damaged or expired batteries.
The product labeling does not adequately warn about risks from damaged or expired batteries.
All model variations of Spacelabs Ultraview DM4 Vital Signs Monitor with model number 91331 and serial numbers up to GFD10486.
No specific stop-use instruction is provided; the recall focuses on labeling improvements, not immediate action.
We’ve drafted a message you can send Zoe Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3099-2024 — Zoe Medical Zoe Medical Hello, I own a Zoe Medical that is covered by recall Z-3099-2024 from Zoe Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
