GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.
This recall has been terminated (originally issued September 30, 2008).
- Company
- Ge Healthcare
- Recall Initiated
- March 29, 2007
- Posted
- September 30, 2008
- Terminated
- February 4, 2012
- Recall Number
- Z-1713-2008
- Quantity
- 132
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.
Distribution
Worldwide Distribution --- USA including states of CA, DE, FL, GA, ID, IL, KS, KY, MD, MI, MO, MT, NC, NJ, NM, NY, OH, PA, SC, TX, UT, VA, and WV, and countries of Australia, Canada, China, France, Germany, Greece, Italy, Korea, Poland, Saudi Arabia, United Kingdom, and Venezuela.
Lot / Code Info
42948HL0, 42949HL8, 43054HL6, 43055HL3, 43056HL1, 43057HL9, 43132HL0, 43133HL8, 43134HL6, 43135HL3, 43201HL3, 43202HL1, 43203HL9, 44605HL4, 44606HL2, 44607HL0, 44608HL8, 44609HL6, 44610HL4, 44681HL5, 45046HL0, 45047HL8, 45048HL6, 45128HL6, 45129HL4, 45130HL2, 45131HL0, 48119HL2, 48120HL0, 48121HL8, 48122HL6, 48123HL4, 48124HL2, 48125HL9, 48126HL7, 48127HL5, 48128HL3, 48164HL8, 48181HL2, 48274HL5, 48276HL0, 48277HL8, 48278HL6, 48680HL3, 48682HL9, 48683HL7, 48684HL5, 48685HL2, 48686HL0, 48687HL8, 48688HL6, 48689HL4, 48876HL7, 48877HL5, 48878HL3, 48995HL3, 48997HL1, 48998HL9, 49000HL3, 49208HL2, 49209HL0, 49210HL8, 49211HL6, 49391HL6, 49392HL4, 49393HL2, 49395HL7, 49494HL8, 49496HL3, 49497HL1, 49498HL9, 49499HL7, 49500HL2, 49501HL0, 49502HL8, 49503HL6, 49681HL0, 49682HL8, 49683HL6, 49684HL4, 49685HL1, 49686HL9, 49687HL7, 49688HL5, 49850HL1, 49851HL9, 49852HL7, 49853HL5, 49855HL0, 49856HL8, 49857HL6, 50027HL2, 50028HL0, 50029HL8, 50030HL6, 50031HL4, 50177HL5, 50178HL3, 50179HL1, 50180HL9, 50321HL9, 50322HL7, 50323HL5, 50324HL3, 50444HL9, 50445HL6, 50446HL4, 50447HL2, 50448HL0, 50449HL8, 50450HL6, 50451HL4, 50452HL2, 50453HL0, 50790HL5, 50791HL3, 50792HL1, 50793HL9, 50794HL9, 50795HL4, 50797HL0, 50798HL8, 50801HL0, 51143HL6, 51144HL4, 51145HL1, 51147HL7, 51486HL9, 51487HL7, 51488HL5, 52014HL8, and 70RD05001
Root Cause
Radiation Control for Health and Safety Act
Action Taken
GE will be correcting the units by replacing all collimators that don't meet the 160-lux requirement. The field correction will be initiated and is scheduled to be completed by October 2008.