PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 2024-02-07 Health serious FDA
Health · FDA · Recall #FDA-Z-0835-2024
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name… Recall
Issued February 7, 2024 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
In February 2024, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled the Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name…, 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
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
What you should do
- 1 Stop using Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. to arrange your voluntary. See the official notice below for contact details.
- 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 7, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-0835-2024
- Made in
- Netherlands
- Issuing agency
- FDA
In context
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 17 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.