—#73745

Product

GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827.

FDA product code: KPR — System, X-Ray, Stationary
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K993090
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-03-29
Posted by FDA: 2008-09-30
Terminated: 2012-02-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.