CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report

Spacelabs Ultraview DM3 Vital Signs Monitor recalled

Zoe Medical is recalling Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT). The recall was initiated on 13 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330-M; UDI-DI 00851920007002; all serial numbers up to FFD8292 Model No. 91330-MT; UDI-DI 00851920007019; all serial numbers up to FFD8292 Model No. 91330-N; UDI-DI 00851920007026; all serial numbers up to FFD8292 Model No. 91330-NT; UDI-DI 00851920007033; all serial numbers up to FFD8292

Quantity recalled6429 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3098-2024
FDA event ID: 95160
Recalling firm: Zoe Medical, Topsfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 Aug 2024
FDA classified: 10 Sep 2024
Reported: 18 Sep 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

13 Aug 2024	Recall initiated by company
10 Sep 2024	Classified by FDA	+28 days
18 Sep 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Where it was distributed

awaiting additional details

Questions about this recall

Why was it 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.

Which lots are affected?

Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330-M; UDI-DI 00851920007002; all serial numbers up to FFD8292 Model No. 91330-MT; UDI-DI 00851920007019; all serial numbers up to FFD8292 Model No. 91330-N; UDI-DI 00851920007026; all serial numbers up to FFD8292 Model No. 91330-NT; UDI-DI 00851920007033; all serial numbers up to FFD8292

Where was it sold?

awaiting additional details

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95160

Reported	Class	Recall	Company	Reason	Where
18 Sep 2024	CLASS II	Spacelabs Ultraview DM4 Vital Signs Monitor recalled	Zoe Medical	Device Malfunction	MA

More recalls from Zoe Medical

All 3

Reported	Class	Recall	Company	Reason	Where
18 Sep 2024Device	CLASS II	Spacelabs Ultraview DM4 Vital Signs Monitor recalled	Zoe Medical	Device Malfunction	MA
26 Sep 2012Device	CLASS II	Spacelabs Ultraview DM3 Monitor recalled by Zoe Medical Incorporated	Zoe Medical	Device Malfunction	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide