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.
FDA Recall Z-3018-2011 · Posted 2011-08-12
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Recalling FirmImaging Sciences International, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2010-12-15
Date Terminated2013-03-01
Product Quantity1
Reason for Recall
Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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