FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Interis Allura BiPlane X-Ray System
- Recall number
- Z-0022-06
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Interis Allura BiPlane X-Ray System
- Status
- Terminated
- Initiated
- 2005-07-27
- Posted
- 2005-08-31
- Terminated
- 2008-05-20
- Reason
- 1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.
- Root cause
- Other
- Action
- A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed.
- Quantity
- 43 units
- Distribution
- Devices were distributed to hospitals/medical centers nationwide.
- Lot, serial or model codes
- The firm utilizes site numbers: 520582, 531926, 535761, 535775, 520949, 530660, 530654, 522136, 521325, 532241, 531939, 520721, 104949, 530396, 532152, 530653, 532383, 531649, 534756, 533290, 521525, 533397, 534786, 520688, 522456, 520964, 532218, 521149, 520275, 532240, 531758, 520666, 519196, 531799, 519981, 520756, 76992, 534131, 506509, 519197, 533288, 537175, 537181
- 510(k) numbers
- ["K002016"]
- PMA numbers
- not on file
- Product code
- JAK
- 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