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

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2023-08-09 Health serious FDA
Health · FDA · Recall #FDA-Z-2284-2023

Azurion 7 M20. X-ray Image guided Therapy System. Recall

Issued August 9, 2023 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

In August 2023, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Azurion 7 M20. X-ray Image guided Therapy System., 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

The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.

What you should do

  1. 1 Stop using Azurion 7 M20. X-ray Image guided Therapy System. 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
August 9, 2023
Units affected
Not reported
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia,
Recall number
FDA-Z-2284-2023
Made in
Netherlands
Issuing agency
FDA

In context

Read the official FDA notice

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