Z-2463-2012Class II

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

Name: Z-2463-2012 DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image...
Creator: Imaging Sciences International, LLC
Published: 2012-07-30
License: https://open.fda.gov/license/

Dental Imaging Technologies Corporation / initiated 2012-07-30 / Terminated / root cause: software

FDA source

Imaging Sciences International, LLC began a recall of DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System on 2012-07-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2463-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-30
Posted: 2012-09-26
Terminated: 2016-10-13
Recalling firm: Dental Imaging Technologies Corporation
Product: DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Product code: LLZ System, Image Processing, Radiological
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)
Root cause tag: software
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2463-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2463-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-26

Product code LLZ

K090461Class IIImage-Arena 4.0 and Ia Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH / cleared 2009-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)