—#41206

Product

Interis Allura BiPlane X-Ray System

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K002016
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Other

Action the firm took

A letter issued on 7/25/05 advising customers of problem. The letter advised that an upgrade will be performed.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Devices were distributed to hospitals/medical centers nationwide.

Timeline

Recall initiated: 2005-07-27
Posted by FDA: 2005-08-31
Terminated: 2008-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41206. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.