Z-2422-2010

DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It...

Name: Z-2422-2010 DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2007-12-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-12-13 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of 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... on 2007-12-13. The reason FDA records is "When using DICOM print functionality, the printed images may contain data for the wrong patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2422-2010
Status: Terminated
Initiated: 2007-12-13
Posted: 2010-09-14
Terminated: 2010-09-14
Recalling firm: Philips North America LLC
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.
Product code: KPR System, X-Ray, Stationary
Reason for recall: When using DICOM print functionality, the printed images may contain data for the wrong patient.
Root cause tag: software
FDA root cause: Software design
Action: 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".
Quantity in commerce: 119 units
Distribution: Nationwide Distribution: including the states of AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI.
Product codes and lots: 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.

Product code KPR

K982795Class IIPhilips Bucky VisionPhilips Medical Systems, Inc. / cleared 1998-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)