FDA Recall Terminated

DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System

Recall: Z-2463-2012 · Initiated July 30, 2012

Recall

Recall Number: Z-2463-2012
Event Number: 62830
Firm: Imaging Sciences International, LLC
FEI Number: 3021551875
Product Code: LLZ
Status: Terminated
Root Cause: Software design
Initiated: July 30, 2012
Posted: September 26, 2012
Terminated: October 13, 2016
Address: 1910 North Penn Rd, Hatfield, PA, 19440-1960

Description

Reason

A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1)

Action

DEXIS sent a Medical Device Corrective Action letter dated July 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. An Acknowledgement Form was included with the notification that is to be returned by the consignee to the recalling firm. Customers were instructed to call DEXIS Technical Support at 888-883-3947 as soon as possible to have Technical Support review and potentially correct any issues that may have resulted from its use. To request a free-of-charge upgrade kit, customers should email a request to [email protected]. For questions regarding this recall call 215-997-5666,

Distribution

Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.

Quantity

366