Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0851-04

GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA

GE Healthcare / initiated 2004-03-30 / Terminated

General Electric Med Systems began a recall of GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA on . The reason FDA records is "The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0851-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B2056HA
Product code
EAM Screen, Intensifying, Radiographic
Reason for recall
The ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
FDA root cause
Other
Action
Field modification instructions were issued on 3/30/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to hospitals.
Quantity in commerce
1236 devices
Distribution
The units were distributed nationwide in the United States and worldwide.
Product codes and lots
All serial numbers