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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 Device Recall DEXIS Imaging Suite see related information
Date Initiated by Firm July 30, 2012
Date Posted September 26, 2012
Recall Status1 Terminated 3 on October 13, 2016
Recall Number Z-2463-2012
Recall Event ID 62830
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 PA 19440-1960
For Additional Information Contact
215-997-5666
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = TOMTEC IMAGING SYSTEMS, GMBH
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