Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed...
General Electric Med Systems LLC began a recall of Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII... on . The reason FDA records is "The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0269-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
- Product code
- IXR Table, Radiographic, Tilting
- Reason for recall
- The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.
- FDA root cause
- Other
- Action
- Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
- Quantity in commerce
- 1150
- Product codes and lots
- Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
