Z-1668-2023 Class II Ongoing
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
- 32 units
Product Description
Intelli-C, Right side suspended Tabletop, REF: 03400000
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: 05713464000527/Serial Numbers: 627004, 627007, 639001, 639002,639003, 639004, 639007, 639010, 647001, 647004, 647005, 648001, 651007, 658002, 658003, 658006, 658010, 666008, 675001, 675004, 682006, 682010