FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: MultiDiagnost Eleva
- Recall number
- Z-0351-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- MultiDiagnost 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
- 46 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- FCO 70800080 Equipment #'s 538440, 544123, 544904, 545156, 545198, 546578, 549417, 551519, 551714, 553287, 553435, 553838, 554283, 554284, 554633, 554640, 556197, 556369, 557258, 41444651, 41445097, 41445127, 41445131, 41445221, 41445237, 41445464, 41445652, 41445800, 41445927, 41455927, 41643223, 41783749, 41849575, 41954854, 42549980, 42799914, 42892004, 42892425, 43319037, 43386703, 43443091, 43453378, 43721197, 44146025, 44401636, and 44653739.
- 510(k) numbers
- not on file
- 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