FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: 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.
- Recall number
- Z-2473-2010
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- 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.
- Status
- Terminated
- Initiated
- 2008-10-23
- Posted
- 2010-09-22
- Terminated
- 2011-08-10
- Reason
- 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
- Other
- Action
- 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.
- Quantity
- 88 units in US
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K984545"]
- PMA numbers
- not on file
- Product code
- IZI
- 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