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

Official notice

18 Sept 2024

Last checked

18 Sept 2024

Medium riskFDA

An official FDA notice concerns Zoe Medical Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 - safety alert. An official FDA notice concerns Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-09-18. Recall numbers: Z-3098-2024. Check the official notice for the complete list. Published 2024-09-18.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

6,429

Recall number

Z-3098-2024

Official notice

2024-09-18

The hazard

An official FDA notice concerns Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-09-18. Recall numbers: Z-3098-2024. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 00851920007002, UDI-DI 00851920007019, UDI-DI 00851920007026, UDI-DI 00851920007033

Event Ids

95160

Recall Numbers

Z-3098-2024

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Affected products

Product 1

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

Units affected

6,429

Risk / hazard

An official FDA notice concerns Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-09-18. Recall numbers: Z-3098-2024. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States · MA · Topsfield

Affected area 1

US · United States · MA · Topsfield

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Zoe Medical. Contact: Zoe Medical Incorporated.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-3098-2024

Event id

95160

Units affected

6,429

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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