FDA Medical Device Recalls (openFDA)
KaVo Dental Technologies LLC: cone-beam CT system
- Recall number
- Z-1101-2019
- Recalling firm
- KaVo Dental Technologies LLC
- Product
- cone-beam CT system
- Status
- Open, Classified
- Initiated
- 2018-12-31
- Posted
- not on file
- Terminated
- not on file
- Reason
- ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
- Root cause
- Device Design
- Action
- Palodex Group Oy sent a Notification letter to affected customers on or about December 31, 2018. The letter identified the affected product, problem and actions to be taken. The firm corrective action is to update the firmware of ORTHOPANTOMOGRAPH OP 3D of the defective units. Acknowledgement to the field correction letter is requested within 30 days from receiving the letter.
- Quantity
- 230
- Distribution
- US distribution in NC
- Lot, serial or model codes
- versions 2.1.0 and 2.1.1
- 510(k) numbers
- ["K170813","K180947"]
- PMA numbers
- not on file
- Product code
- OAS
- Firm FEI
- 1017522
- Firm city
- Charlotte
- Firm state
- NC
- 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