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Serious recall: Injury is possible or has been reported. Take action promptly.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2023-06-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1647-2023

Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and… Recall

Issued June 7, 2023 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

In June 2023, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

What you should do

  1. 1 Stop using Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health
Recall date
June 7, 2023
Units affected
Not reported
Sold at
Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile C
Recall number
FDA-Z-1647-2023
Made in
Netherlands
Issuing agency
FDA

In context

Read the official FDA notice

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