Reported Sep 18, 2024 · Ongoing
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
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 DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
- Lot codes and dates
15 of 15 products
Products covered by this recall Model / number Barcodes Product as published 91330— — no UDI-DI (distributed prior to UDI regulation) 91330all serial numbers up to FFD8292 — no UDI-DI (distributed prior to UDI regulation) 91330all serial numbers up to FFD8292 — no UDI-DI (distributed prior to UDI regulation) 91330-Mall serial numbers up to FFD8292 — 00851920007002UDI-DI 00851920007002 91330-MTall serial numbers up to FFD8292 — 00851920007019UDI-DI 00851920007019 91330-Nall serial numbers up to FFD8292 — 00851920007026UDI-DI 00851920007026 91330-NTall serial numbers up to FFD8292 — 00851920007033UDI-DI 00851920007033 — all serial numbers up to FFD8292 - Amount recalled
- 6429 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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