FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Allura XPER 10/10
- Recall number
- Z-0344-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Allura XPER 10/10
- Status
- Terminated
- Initiated
- 2008-12-10
- Posted
- 2009-09-24
- Terminated
- 2012-08-17
- Reason
- Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
- Quantity
- 104 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- FCO 72200124 and 72200125 for 1st phase FCO 72200133 for 2nd phase Equipment #'s: 103281, 103283, 505903, 506119, 530653, 532614, 533397, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537631, 537804, 538028, 538157, 538387, 538409, 538514, 538516, 539326, 539628, 540184, 540237, 541577, 541589, 541590, 542413, 542557, 542714, 543200, 543289, 543411, 543879, 543989, 544395, 544433, 545025, 545396, 545604, 545753, 545884, 545997, 546013, 546569, 547173, 547769, 547823, 547922, 548140, 548288, 549368, 549903, 551855, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444647, 41444650, 41445448, 41445501, 41445538, 41455885, 41455897, 41455920, 41780160, 42057324, and 42064724. Additional Equipment #s from phase 2- 10107, 101110, 101205, 557729, 557908, 41443609, 41445432, 41446024, 41446262, 41660520, 42046440, 42064058, 42394072, 42553772, 42625859, 42891704, 43043666, 43164789, 43173591, 43453735, 43848923, 43931292, 44028554, 44066424, 44193760, 44892370, and 47140511.
- 510(k) numbers
- ["K031333","K984545"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28