Philips Medical Systems North America Co. Phillips Philips Digital Diagnost X-Ray system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Digital Diagnost X-Ray system
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
Site numbers 103982, 104073, 105158, 105629, 504343, 505773. Added sites: 104303, 38280, 44807, 59667, 76907, 76909, 76974, 82641, 82652, 82657, 82724, 83072, 83073, 84712, 84862, 84863, 86072, 86987, 86988, 102030, 102100, 102489, 102713, 102717, 102719, 102787, 102905, 102911, 103109, 103165, 103274, 103437, 103438, 103439, 103453, 103893, 103894, 103941, 104465, 104902, 104903, 104904, 104937, 104938, 105415, 105621, 105623, 105625, 105668, 250094, 250470, 250471, 250875, 500002, 504546, 504989, 505038, 505347, 505350, 505351, 505352, 505605, 505684, 505944, 506184, 506343, 506643, 506645, 506826, 506839, 506848, 519148, 519149, 519150, 519568, 519739, 519904, 520297, 520298, 520299, 520385, 520687, 520698, 520766, 520808, 520811, 520828, 520836, 520978, 520984, 520986, 521004, 521089, 521110, 521412, 521539, 521660, 521668, 521893, 521894, 521995, 521997, 522213, 522215, 522244, 522281, 522360, 522361, 522362, 522364, 522367, 522398, 522475, 530411, 530412, 530415, 530455, 530516, 530611, 530696, 530716, 530779, 530787, 530789, 530791, 530792, 530796, 530800, 530806, 531773, 531825, 531833, 531858, 531975, 531994, 531995, 532138, 532141, 532167, 532168, 532169, 532171, 532206, 532211, 532278, 532364, 532421, 532422, 532815, 532816, 532817, 532818, 533244, 533317, 533319, 533338, 533426, 533468, 533534, 533571, 533769, 533915, 533916, 533920, 533949, 533950, 534082, 534279, 534435, 534539, 534570, 534622, 534718, 534800, 534801, 534836, 534866, 535146, 535334, 535381, 535383, 535549, 535626, 535773, 535774, 535786, 535933, 536002, 536039, 536043, 536062, 536064, 536128, 536129, 536441, 536448, 536614, 536913, 536939, 537163, 537184, 537455, 537753, 537755, 537762, 537840, 537918, 537948, 537950, 537974, 538139, 538154, 538166, 538304, 538437, 538478, 539680, 540173, 540199, 540474, 540477, 542194, 543376, 545097, 549011, 549725, and 557777.
Products Sold
Site numbers 103982, 104073, 105158, 105629, 504343, 505773. Added sites: 104303, 38280, 44807, 59667, 76907, 76909, 76974, 82641, 82652, 82657, 82724, 83072, 83073, 84712, 84862, 84863, 86072, 86987, 86988, 102030, 102100, 102489, 102713, 102717, 102719, 102787, 102905, 102911, 103109, 103165, 103274, 103437, 103438, 103439, 103453, 103893, 103894, 103941, 104465, 104902, 104903, 104904, 104937, 104938, 105415, 105621, 105623, 105625, 105668, 250094, 250470, 250471, 250875, 500002, 504546, 504989, 505038, 505347, 505350, 505351, 505352, 505605, 505684, 505944, 506184, 506343, 506643, 506645, 506826, 506839, 506848, 519148, 519149, 519150, 519568, 519739, 519904, 520297, 520298, 520299, 520385, 520687, 520698, 520766, 520808, 520811, 520828, 520836, 520978, 520984, 520986, 521004, 521089, 521110, 521412, 521539, 521660, 521668, 521893, 521894, 521995, 521997, 522213, 522215, 522244, 522281, 522360, 522361, 522362, 522364, 522367, 522398, 522475, 530411, 530412, 530415, 530455, 530516, 530611, 530696, 530716, 530779, 530787, 530789, 530791, 530792, 530796, 530800, 530806, 531773, 531825, 531833, 531858, 531975, 531994, 531995, 532138, 532141, 532167, 532168, 532169, 532171, 532206, 532211, 532278, 532364, 532421, 532422, 532815, 532816, 532817, 532818, 533244, 533317, 533319, 533338, 533426, 533468, 533534, 533571, 533769, 533915, 533916, 533920, 533949, 533950, 534082, 534279, 534435, 534539, 534570, 534622, 534718, 534800, 534801, 534836, 534866, 535146, 535334, 535381, 535383, 535549, 535626, 535773, 535774, 535786, 535933, 536002, 536039, 536043, 536062, 536064, 536128, 536129, 536441, 536448, 536614, 536913, 536939, 537163, 537184, 537455, 537753, 537755, 537762, 537840, 537918, 537948, 537950, 537974, 538139, 538154, 538166, 538304, 538437, 538478, 539680, 540173, 540199, 540474, 540477, 542194, 543376, 545097, 549011, 549725, and 557777.
Philips Medical Systems North America Co. Phillips is recalling Philips Digital Diagnost X-Ray system due to Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.
Recommended Action
Per FDA guidance
On 7/23/07 Philips mailed a letter dated July 9, 2007 titled Electronic Product Radiation Warning. The letter advises customers of the issue and asks that customers apply the enclosed cautionary label to the device. The letter also explains that there will be a system modification to be installed. On 8/20/07 the firm sent the same letter, along with a letter dated 8/20/07 to customers thought to have either scrapped their units and the customer had previously indicated they were no longer using the unit. The 8/20/07 letter requested the customer contact Philps if they are currently using the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026