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

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2025-02-12 Health serious FDA
Health · FDA · Recall #FDA-Z-1087-2025

Azurion 3 M12 System Code: (1) 722063 (2) 722221 Recall

Issued February 12, 2025 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

In February 2025, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Azurion 3 M12 System Code: (1) 722063 (2) 722221, 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 safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

What you should do

  1. 1 Stop using Azurion 3 M12 System Code: (1) 722063 (2) 722221 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
February 12, 2025
Units affected
Not reported
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria,
Recall number
FDA-Z-1087-2025
Made in
Netherlands
Issuing agency
FDA

In context

Read the official FDA notice

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