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.
FDA Recall Z-2422-2010 · Posted 2010-09-14
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeKPR
Date Initiated2007-12-13
Date Terminated2010-09-14
Product Quantity119 units
Reason for Recall
When using DICOM print functionality, the printed images may contain data for the wrong patient.
Firm 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".
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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