FDA Medical Device Recalls (openFDA)
DeGotzen: DeGotzen XRay unit XGenus Dental X-ray unit.
- Recall number
- Z-1020-2013
- Recalling firm
- DeGotzen
- Product
- DeGotzen XRay unit XGenus Dental X-ray unit.
- Status
- Terminated
- Initiated
- 2012-09-26
- Posted
- 2013-04-17
- Terminated
- 2018-05-07
- Reason
- It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
- Root cause
- Radiation Control for Health and Safety Act
- Action
- DeGotzen will add new labeling or change existing labeling to correct for the 5 mentioned deficiencies. This correction of the noncompliant products must be made at no cost to the customers. For further questions please call 800-289-6367 ext. 390.
- Quantity
- 159 units
- Distribution
- US (nationwide)
- Lot, serial or model codes
- 766471
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EAP
- Firm FEI
- 3002994636
- Firm city
- Olgiate Olona Varese
- Firm state
- not on file
- Firm country
- Italy
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