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 / numberBarcodesProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.