Philips Medical Systems North America Co. Phillips Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Serial numbers affected: 18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691.
Products Sold
Serial numbers affected: 18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691.
Philips Medical Systems North America Co. Phillips is recalling Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 due to Inaccurate anatomical measurements when using the optional SmartMask feature. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate anatomical measurements when using the optional SmartMask feature
Recommended Action
Per FDA guidance
The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.
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