FDA Medical Device Recalls (openFDA)
Imaging Sciences International, LLC: Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
- Recall number
- Z-1265-2009
- Recalling firm
- Imaging Sciences International, LLC
- Product
- Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
- Status
- Terminated
- Initiated
- 2009-01-08
- Posted
- 2009-05-22
- Terminated
- 2009-06-04
- Reason
- faulty calibration
- Root cause
- Nonconforming Material/Component
- Action
- Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.
- Quantity
- 24 units
- Distribution
- Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
- Lot, serial or model codes
- Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.
- 510(k) numbers
- ["K061284"]
- PMA numbers
- not on file
- Product code
- MUH
- 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