Z-0022-06

Interis Allura BiPlane X-Ray System

Name: Z-0022-06 Interis Allura BiPlane X-Ray System
Creator: Philips Medical Systems North America Co. Phillips
Published: 2005-07-27
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-07-27 / Terminated

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Interis Allura BiPlane X-Ray System on 2005-07-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0022-06
Status: Terminated
Initiated: 2005-07-27
Posted: 2005-08-31
Terminated: 2008-05-20
Recalling firm: Philips North America LLC
Product: Interis Allura BiPlane X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
FDA 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 in commerce: 43 units
Distribution: Devices were distributed to hospitals/medical centers nationwide.
Product codes and lots: 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

Product code JAK

K002016Class IIPhilips Integris AlluraPhilips Medical Systems North America, Inc. / cleared 2000-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)