Z-1101-2019Class II

cone-beam CT system

Name: Z-1101-2019 cone-beam CT system
Creator: KaVo Dental Technologies LLC
Published: 2018-12-31
License: https://open.fda.gov/license/

KaVo Dental Technologies, LLC / initiated 2018-12-31 / Open, Classified / root cause: design

FDA source

KaVo Dental Technologies LLC began a recall of cone-beam CT system on 2018-12-31. FDA classified it as Class II and gives the reason as "ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1101-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-12-31
Posted: 2019-04-22
Recalling firm: KaVo Dental Technologies, LLC
Product: cone-beam CT system
Product code: OAS X-Ray, Tomography, Computed, Dental
Reason for recall: ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Root cause tag: design
FDA 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 in commerce: 230
Distribution: US distribution in NC
Product codes and lots: versions 2.1.0 and 2.1.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1101-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1101-2019	Class II	Ongoing	FDA Mandated	2019-05-01	2019-04-22

Product code OAS

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)