Z-1020-2013Class II

DeGotzen XRay unit XGenus Dental X-ray unit

Name: Z-1020-2013 DeGotzen XRay unit XGenus Dental X-ray unit
Creator: DeGotzen
Published: 2012-09-26
License: https://open.fda.gov/license/

De Gotzen S.r.l. / initiated 2012-09-26 / Terminated / root cause: labeling and UDI

FDA source

DeGotzen began a recall of DeGotzen XRay unit XGenus Dental X-ray unit on 2012-09-26. FDA classified it as Class II and gives the reason as "It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1020-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-26
Posted: 2013-04-17
Terminated: 2018-05-07
Recalling firm: De Gotzen S.r.l.
Product: DeGotzen XRay unit XGenus Dental X-ray unit.
Product code: EAP Unit, X-Ray, Intraoral
Reason for recall: It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification
Root cause tag: labeling and UDI
FDA 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 in commerce: 159 units
Distribution: US (nationwide)
Product codes and lots: 766471

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1020-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code EAP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)