FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-3018-2011
- Recalling firm
- Imaging Sciences International, LLC
- 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.
- Status
- Terminated
- Initiated
- 2010-12-15
- Posted
- 2011-08-12
- Terminated
- 2013-03-01
- 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
- Lot, serial or model codes
- Part number 9140-0035 (Tube head) and 9140-1001 (Power Supply)
- 510(k) numbers
- ["K051980"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3021551875
- Firm city
- Hatfield
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28