FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: OminDiagnost Eleva
- Recall number
- Z-0352-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- OminDiagnost Eleva
- 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
- 69 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- FCO 70800085 Equipment #'s 102666, 103056, 104083, 104136, 104530, 104838, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506236, 506247, 519141, 519142, 519574, 519952, 520020, 520046, 521113, 521977, 522220, 530589, 530777, 532087, 532140, 532151, 532213, 532703, 533112, 533314, 533471, 533473, 533559, 534247, 535257, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539106, 539598, 539990, 540252, 541263, 541490, 543272, 544059, 545014, 545841, 546031, 547017, 547348, 549798, 553676, 558404, 42036161, 42383151, 43180366, 43180367, and 43680651,
- 510(k) numbers
- ["K032046"]
- PMA numbers
- not on file
- Product code
- JAA
- 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