FDA Recall Terminated

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: Z-2422-2010 · Initiated December 13, 2007

Recall

Recall Number: Z-2422-2010
Event Number: 47477
Firm: Philips Medical Systems North America Co. Phillips
FEI Number: 1000524572
Product Code: KPR
Status: Terminated
Root Cause: Software design
Initiated: December 13, 2007
Posted: September 14, 2010
Terminated: September 14, 2010
Address: 22100 Bothell Everett Hwy, Bothell, WA, 98021-8431

Description

Reason

When using DICOM print functionality, the printed images may contain data for the wrong patient.

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".

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.

Quantity

119 units