Recall Z-3018-2011 ยท JAK System, X-Ray, Tomography, Computed
Imaging Sciences International, LLC
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.
| Date | Aug 12, 2011 (initiated Dec 15, 2010) |
| Status | Terminated |
| Reason | Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply |
| 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: darin.oppenheimer@imagingsciences.com. 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051980 | DVT SCANNER Imaging Sciences Intl., Inc., Aug 19, 2005 |