510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1883-2008

GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North...

GE Healthcare / initiated 2008-01-02 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

GE Healthcare began a recall of GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use... on . The reason FDA records is "Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1883-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy.
Product code
KPR System, X-Ray, Stationary
Reason for recall
Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required
Root cause tag
labeling and UDI
FDA root cause
Radiation Control for Health and Safety Act
Action
GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance.
Quantity in commerce
668 (419 US / 249 OUS)
Distribution
AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Malta, Martinique (French), Netherlands, Norway, Palestine, Portugal, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and Yugoslavia,
Product codes and lots
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