FDA Medical Device Recalls (openFDA)
Imaging Sciences International, LLC: i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.
- Recall number
- Z-0543-2010
- Recalling firm
- Imaging Sciences International, LLC
- Product
- i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects.
- Status
- Terminated
- Initiated
- 2009-10-30
- Posted
- 2009-12-17
- Terminated
- 2010-09-30
- Reason
- overhead carriage drops quickly
- Root cause
- Device Design
- Action
- Imaging Sciences International issued an "Urgent Medical Device Recall" notification dated October 30, 2009 to all customers informing them of the problem and that a field service representative would schedule a visit to install an upgrade kit. For further information, contact Imaging Sciences International at 1-800-205-3570, option 5.
- Quantity
- 98 units
- Distribution
- Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.
- Lot, serial or model codes
- Serial Numbers: ICU070427, ICU070428, ICU070429, ICU070430, ICU070432, ICU070433, ICU070434, ICU070435, ICU070436, ICU070437, ICU070438, ICU070439, ICU070440, ICU070441, ICU070442, ICU070443, ICU070445, ICU070446, ICU070447, ICU070448, ICU070449, ICU070451, ICU070452, ICU070453, ICU070454, ICU070455, ICU070456, ICU070457, ICU070458, ICU070459, ICU070460, ICU070461, ICU070462, ICU070463, ICU070464, ICU070465, ICU070466, ICU070467, ICU070468, ICU070469, ICU070470, ICU070471, ICU070472, ICU070473, ICU070474, ICU070475, ICU070476, ICU070477, ICU070478, ICU070479, ICU070480, ICU070481, ICU070482, ICU070483, ICU070484, ICU070485, ICU070486, ICU070487, ICU070488, ICU070489, ICU070490, ICU070491, ICU070492, ICU070493, ICU070494, ICU070495, ICU070497, ICU070498, ICU070499, ICU070500, ICU070501, ICU070502, ICU070503, ICU070505, ICU070506, ICU070507, ICU070508, ICU070509, ICU070510, ICU070512, ICU070513, ICU070514, ICU070515, ICU070516, ICU070517, ICU070518, ICU070519, ICU070520, ICU070521, ICU070522, ICU070523, ICU070524, ICU070525, ICU070527, ICU070528, ICU070529, ICU070530, ICU070531 and ICU070532.
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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