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Xstrahl Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system - safety alert

Official notice

22 Dec 2021

Last checked

22 Dec 2021

Medium riskFDA

An official FDA notice concerns Xstrahl Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system - safety alert. An official FDA notice concerns Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-12-22. Recall numbers: Z-0389-2022. Check the official notice for the complete list. Published 2021-12-22.

What to do now

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

Units affected

120

Recall number

Z-0389-2022

Official notice

2021-12-22

The hazard

An official FDA notice concerns Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-12-22. Recall numbers: Z-0389-2022. 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

88545

Recall Numbers

Z-0389-2022

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Affected products

Product 1

Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system

Units affected

120

Risk / hazard

An official FDA notice concerns Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2021-12-22. Recall numbers: Z-0389-2022. 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

GB · United Kingdom · Walsall

Affected area 1

GB · United Kingdom · Walsall

Affected area 2

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Xstrahl. Contact: Xstrahl Limited.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0389-2022

Event id

88545

Units affected

120

Status

terminated

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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