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Spacelabs Healthcare - safety alert

Official notice

12 Nov 2025

Last checked

12 Nov 2025

Medium riskFDA

An official FDA notice concerns Spacelabs Healthcare - safety alert. An official FDA notice concerns Spacelabs Healthcare. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-11-12. Recall numbers: Z-0416-2026. Check the official notice for the complete list. Published 2025-11-12.

What to do now

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

Units affected

142

Recall number

Z-0416-2026

Official notice

2025-11-12

The hazard

An official FDA notice concerns Spacelabs Healthcare. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-11-12. Recall numbers: Z-0416-2026. 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.

Event Ids

97686

Recall Numbers

Z-0416-2026

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Where it was sold

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

Location 1

GB · United Kingdom · N/A · Hertford

Affected area 1

GB · United Kingdom · N/A · Hertford

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Spacelabs Healthcare. Contact: Spacelabs Healthcare, Ltd..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0416-2026

Event id

97686

Units affected

142

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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