Zoe Medical recalls Spacelabs Ultraview DM3 Vital Signs Monitors with model 91330 due to inadequate battery safety warnings. Owners should check serial numbers up to FFD8292 for affected units.
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 DM3 Vital Signs Monitors (all variations) because the product's labeling doesn't warn about risks from damaged or expired batteries. This could lead to potential safety issues if batteries are not properly maintained.
The product's labeling fails to adequately warn about risks when batteries are damaged or have exceeded their intended use life. This could potentially cause safety hazards if users do not follow proper battery maintenance procedures.
Users of Spacelabs Ultraview DM3 Vital Signs Monitors with model numbers 91330 and serial numbers up to FFD8292 are affected. Patients using these monitors for medical monitoring are most at risk.
Check for the model number 91330 on the device. Affected units have serial numbers up to FFD8292. The product was distributed before UDI regulations were implemented.
Identify the model number on your Spacelabs Ultraview DM3 Vital Signs Monitor. Affected units have model numbers 91330 with variations -M, -MT, -N, or -NT.
Check if your device's serial number is up to FFD8292. This is the cutoff for affected units.
The product labeling does not adequately warn about risks from damaged or batteries past their intended use life.
Check your device's model number and serial number to see if it's affected. If it is, contact Zoe Medical for further instructions.
The recall is due to inadequate labeling about battery risks, but no specific safety incidents have been reported.
We’ve drafted a message you can send Zoe Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3098-2024 — Zoe Medical Zoe Medical Hello, I own a Zoe Medical that is covered by recall Z-3098-2024 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.
