FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Integris BH5000
- Recall number
- Z-0346-2009
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Integris BH5000
- Status
- Terminated
- Initiated
- 2008-12-10
- Posted
- 2009-09-24
- Terminated
- 2012-08-17
- Reason
- Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Electronic Product Radiation Warning, dated October 2008, was sent to customers. The letter identified the problem and under what circumstances that it could occur; the actions that should be taken by the customer/user to prevent risks for patients or users; and the actions planned by Philips to correct the problem. Further information or support concerning the issue could be obtained by contacting Bob Pettis at 425-487-7469 or the Philips Call Center at 800-722-9377. Firm FCO tracking numbers 72200107, 72200108, 72200111, 72200112, 72200117, 72200118, 72200119, 72200122, 72200123, 72200124, 72200125, 72200129, 72200142, 7989980, 7080085, 70600034, 70600035, 72200132, 72200133, 72200137, 72200138, 72200140 and 72200141. C & R # 1217116-10/20/08-016C
- Quantity
- 190 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- FCO 72200129 for 1st phase FCO 72200137 or 72200140 or 72200138 or 72200141 for 2nd phase Equipment #'s 33290, 76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386, 104628, 104926, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504733, 504742, 504779, 504868, 504903, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 506008, 506026, 506069, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520582, 520666, 520688, 520756, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530654, 530660, 531649, 531758, 531799, 531939, 532152, 532218, 532240, 532241, 532383, 533288, 534786, 535345, 535761, 535775, 537175, 537593, 538172, 549832, and 44147585. Additional Equipment #s from Phase 2 - 6967, 10329, 13290, 13294, 13511, 13992, 13993, 14021, 17500, 17626, 25974, 25992, 26064, 35437,, 35485, 37908, 38017, 38028, 38062, 38109, 38329, 38426, 38790, 38792, 38933, 41050, 41080, 41115, 41129, 41340, 41355, 41411, 41423, 41455, 41458, 44714, 44719, 47106, 47127, 50375, 50388, 50392, 50419, 52465, 52470, 52488, 59390, 59418, 59422, 62508, 62519, 62531, 62559, 62606, 62671, 62775, 62776, 62779, 62792, 62806, 62968, 62998, 68255, 76198, 76365, 76395, 76460, 76560, 76572, 76580, 76941, 76953, 82519, 82521, 82608, 82609, 82663, 82709, 83311, 83327, 83823, 83834, 83927, 84469, 84487, 84734, 84827, 85018, 85095, 85150, 85497, 86087, 86415, 86419, 86992, 87068, 87186, 100641, 102523, 102790, 102949, 103003, 104388, 250073, 520720, 542784, 557725, 557726, 557738, 557740, 557761, 557762, 557767, 557770, 557773, 557957, 558028, 558180, 558183, 558287,49788214, 49788954, and 49794641.
- 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