ClearanceBrief
Recall Z-0851-04 ยท EAM Screen, Intensifying, Radiographic

General Electric Med Systems

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

DateJul 20, 2004 (initiated Mar 30, 2004)
StatusTerminated
ReasonThe ball joint that attaches the single monitor platform to the system boom could fail causing the monitor to fall.
Root causeOther
ActionField 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.
Quantity1236 devices
DistributionThe units were distributed nationwide in the United States and worldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K760466TABLE, X-RAY, RFX CLASSICAL
General Electric Co., Aug 26, 1976
K801320SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
General Electric Co., Jul 21, 1980