FDA Device recall Z-1669-2023
Intelli-C, Left side suspended Tabletop, REF: 03400010
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Intelli-C, Left side suspended Tabletop, REF: 03400010 by Nrt X Ray A S, citing there is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the moveme….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1669-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-27 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nrt X Ray A S |
| Distribution | US |
Product
Intelli-C, Left side suspended Tabletop, REF: 03400010
Reason
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
Identifiers
| code_info | UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1669-2023%22
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