PlainRecalls
FDA Devices Moderate Class II Ongoing

Allura Xper FD10 and FD20. X-ray Imaging System.

Reported: August 9, 2023 Initiated: June 12, 2023 #Z-2283-2023

Product Description

Allura Xper FD10 and FD20. X-ray Imaging System.

Reason for Recall

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

Details

Units Affected
648 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kenya, South Korea, Libya, Lithuania, Malaysia, Maldives, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Vietnam.
Location
Best, N/A

Frequently Asked Questions

What product was recalled?
Allura Xper FD10 and FD20. X-ray Imaging System.. Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Units affected: 648 units.
Why was this product recalled?
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2283-2023.