i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from ima
FDA device recall Z-3018-2011 · posted 2011-08-12 · Terminated
Recall details
- Recalling firm
- Imaging Sciences International, LLC
- Reason for recall
- Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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
- Date initiated
- 2010-12-15
- Date posted
- 2011-08-12
- Date terminated
- 2013-03-01
- Location
- Hatfield, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DVT SCANNER (K051980) | Imaging Sciences Intl., Inc. | 2005-08-19 |