Z-3018-2011

i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional...

Name: Z-3018-2011 i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional...
Creator: Imaging Sciences International, LLC
Published: 2010-12-15
License: https://open.fda.gov/license/

Dental Imaging Technologies Corporation / initiated 2010-12-15 / Terminated

FDA source

Imaging Sciences International, LLC began a recall of i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray... on 2010-12-15. The reason FDA records is "Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3018-2011
Status: Terminated
Initiated: 2010-12-15
Posted: 2011-08-12
Terminated: 2013-03-01
Recalling firm: Dental Imaging Technologies Corporation
Product: i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply
FDA root cause: Other
Action: The firm, Imaging Sciences, sent an "Urgent Medical Device Field Correction" letter dated December 15, 2011 via first class USPS to its customer. The letter noted the product and described the problem and action to be taken. The customer was instructed to complete and return the ACKNOWLEDGEMENT FORM via fax to 215-997-5665 or email: [email protected]. Imaging Sciences stated in the letter that an X-ray tube head and power supply will be provided and installed by one of their technicians. Should you have any questions regarding this information, call 215-622-1545.
Quantity in commerce: 1
Distribution: X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
Product codes and lots: Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)

Product code JAK

K051980Class IIDvt ScannerImaging Sciences Intl., Inc. / cleared 2005-08-19

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)