Z-1669-2023 Class II Ongoing
FDA device recall Z-1669-2023 was initiated by NRT X-RAY A/S on April 27, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 13 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2023
- Initiation Date
- April 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
Product Description
Intelli-C, Left side suspended Tabletop, REF: 03400010
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA, NV, NY.
Code Information
UDI-DI:05713464000121/Serial Numbers: 647009, 651002, 651006, 666009, 682003