FDA Device recall Z-1101-2019
cone-beam CT system
- FDA Device
- Class II
- ongoing
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of cone-beam CT system by Kavo Dental Technologies, citing ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1101-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-31 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Kavo Dental Technologies |
| Distribution | NC |
Product
cone-beam CT system
Reason
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
Identifiers
| code_info | versions 2.1.0 and 2.1.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1101-2019%22
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