| Class 2 Device Recall DEXIS Imaging Suite | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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