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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Imaging Sciences International, LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
Imaging Sciences International, LLC is recalling i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA due to overhead carriage drops quickly. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
overhead carriage drops quickly
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026