Reported Sep 18, 2024 · Ongoing
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Zoe Medical Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zoe Medical Incorporated · 460 Boston St · Topsfield, MA · 01983-1223
Is this the product you have?
- Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published 91331-M— — 00851920007347UDI-DI 00851920007347 91331-MFall serial numbers up to GFD10486 — 00851920007354UDI-DI 00851920007354 91331-Nall serial numbers up to GFD10486 — 00851920007309UDI-DI 00851920007309 91331-NFall serial numbers up to GFD10486 — 00851920007316UDI-DI 00851920007316 91331-MWall serial numbers up to GFD10486 — 00851920007361UDI-DI 00851920007361 91331-MFWall serial numbers up to GFD10486 — 00851920007378UDI-DI 00851920007378 91331-NWall serial numbers up to GFD10486 — 00851920007323UDI-DI 00851920007323 91331-NFWall serial numbers up to GFD10486 — 00851920007330UDI-DI 00851920007330 — all serial numbers up to GFD10486 - Amount recalled
- 1506 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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