Philips Medical Systems North America Co. Phillips DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identified with Part Number 4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2. The device is manufactured by Philips Medical Systems DMC GmbH, RontgenstraBe 24, 22335 Hamburg, Germany.
Brand
Philips Medical Systems North America Co. Phillips
Lot Codes / Batch Numbers
119 units are identified with Site Numbers: 59667, 82641, 82681, 86222, 86987, 86988, 103893, 103894, 104465, 104937, 104938, 105367, 504989, 505545, 506776, 532141, 536043, 536913, 539410, 540477, 540996, 541079, 541086, 541856, 541857, 542605, 542606, 543430, 544119, 544135, 544487, 544632, 544634, 544658, 545606, 547799, 548185, 548186, 548245, 548391, 548392, 548670, 549294, 549418, 549428, 549651, 549876, 549877, 549912, 550016, 550021, 550071, 550229, 550262, 550271, 550343, 550352, 550357, 550359, 550361, 550362, 550363, 550414, 550415, 550417, 550418, 550547, 550828, 550846, 550874, 550878, 550891, 550937, 551006, 551022, 551574, 551668, 551673, 552375, 552378, 552380, 552404, 552457, 552641, 553014, 553272, 553273, 553421, 553424, 553573, 553607, 554063, 554335, 554354, 554359, 554422, 554449, 554517, 554711, 554714, 554771, 555163, 555164, 555534, 555685, 555754, 553017, 531994, 535549, 543218, 543847, 547216, 549742, 550312, 551522, 552507, 552876, 552914, and 555119.
Products Sold
119 units are identified with Site Numbers: 59667, 82641, 82681, 86222, 86987, 86988, 103893, 103894, 104465, 104937, 104938, 105367, 504989, 505545, 506776, 532141, 536043, 536913, 539410, 540477, 540996, 541079, 541086, 541856, 541857, 542605, 542606, 543430, 544119, 544135, 544487, 544632, 544634, 544658, 545606, 547799, 548185, 548186, 548245, 548391, 548392, 548670, 549294, 549418, 549428, 549651, 549876, 549877, 549912, 550016, 550021, 550071, 550229, 550262, 550271, 550343, 550352, 550357, 550359, 550361, 550362, 550363, 550414, 550415, 550417, 550418, 550547, 550828, 550846, 550874, 550878, 550891, 550937, 551006, 551022, 551574, 551668, 551673, 552375, 552378, 552380, 552404, 552457, 552641, 553014, 553272, 553273, 553421, 553424, 553573, 553607, 554063, 554335, 554354, 554359, 554422, 554449, 554517, 554711, 554714, 554771, 555163, 555164, 555534, 555685, 555754, 553017, 531994, 535549, 543218, 543847, 547216, 549742, 550312, 551522, 552507, 552876, 552914, and 555119.
Philips Medical Systems North America Co. Phillips is recalling DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Dete due to When using DICOM print functionality, the printed images may contain data for the wrong patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When using DICOM print functionality, the printed images may contain data for the wrong patient.
Recommended Action
Per FDA guidance
Philips Healthcare issued an "URGENT PRODUCT CORRECTION " letter dated March 10, 2008 to their consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Validate that image and patient information are correct on hard copy prints. 2) Reprint images that have mixed patient information, and re-check that image and patient information are correct. 3) Do not use printed images if the information is incorrect. The firm will issue the Field Change Order (FCO) 71200025 and the field service engineers will visit each consignee and conduct a software upgrade to solves the printing problem. The consignees may contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 71200025".
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