Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0269-05

Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed...

GE Healthcare / initiated 2004-10-21 / Terminated

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