Philips Medical Systems North America Co. Phillips Allura Xper FD 20/10 x-ray, and fluoroscopy Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Allura Xper FD 20/10 x-ray, and fluoroscopy
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
82, 33, 73, 24, 36, 71, 34, 52, 18, 19, 56, 67, 32, 22, 23, 54, 74, 69, 38
Products Sold
82, 33, 73, 24, 36, 71, 34, 52, 18, 19, 56, 67, 32, 22, 23, 54, 74, 69, 38
Philips Medical Systems North America Co. Phillips is recalling Allura Xper FD 20/10 x-ray, and fluoroscopy due to Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
Recommended Action
Per FDA guidance
On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026