—#74764

Product

Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet). Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K984545
Affected lot / code info: Devices are identified with Site Numbers: 103581, 105399, 104386, 105184, 105585, 104021, 105581, 505120, 104020, 504733, 505067, 104068, 504868, 504921, 504674, 505068, 504903, 104628, 105654, 505530, 505703, 505380, 504655, 104926, 504779, 506026, 505611, 506069, 506119, 504742, 104497, 506008, 505903, 506655, 103921, 531926, 519136, 505356, 104950, 519118, 103526, 104953, 104953, 519730, 520949, 520275, 104959, 76992, 520582, 519981, 521525, 519196, 521325, 521149, 522456, 506509, 520688, 44147585, 530653, 531939, 530654, 522136, 520666, 530660, 520964, 532383, 531649, 531799, 532218, 532152, 520756, 533290, 532240, 530396, 532241, 534131, 531758, 534786, 535761, 535775, 519197, 548140, 537175, 533288, 535345, 537593, 538172, and 534156.

Why it was recalled

A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.

Root cause (FDA determination)

Other

Action the firm took

The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2008-10-23
Posted by FDA: 2010-09-22
Terminated: 2011-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.