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U.S. Department of Health and Human Services

Class 2 Device Recall DEXIS Imaging Suite

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 Class 2 Recall
DEXIS Imaging Suite
see related information
Date Posted September 26, 2012
Recall Status1 Open
Recall Number Z-2463-2012
Recall Event ID 62830
Premarket Notification
510(K) Number
K090461 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Code Information Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3
Recalling Firm/
Manufacturer
Imaging Sciences International, LLC
1910 North Penn Rd
Hatfield, Pennsylvania 19440-1960
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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)
FDA Determined
Cause 2
DESIGN: Software Design
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 orders@dexis.com. For questions regarding this recall call 215-997-5666,.
Quantity in Commerce 366
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = TOMTEC IMAGING SYSTEMS, GMBH
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