510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-1882-2008

GE Healthcare Definium 8000 Digital Radiographic System

GE Healthcare / initiated 2008-03-07 / Terminated / root cause: software
FDA source (opens on fda.gov)

GE Healthcare began a recall of GE Healthcare Definium 8000 Digital Radiographic System on . The reason FDA records is "Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1882-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Healthcare Definium 8000 Digital Radiographic System.
Product code
KPR System, X-Ray, Stationary
Reason for recall
Radiation dose reading greater than actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may impact patient safety. Occasional generator software errors may cause light X-ray Images with reported mAs readings higher than was actually exposed to the patient using the overhead X-ray tube. The mAs rea
Root cause tag
software
FDA root cause
Software design
Action
GE sent a Product Safety Notification dated March 7, 2008 to all customers. The letter described the safety issue, affected product, and stated that a GE Healthcare Field Engineer will schedule a field visit to install software updates.
Quantity in commerce
454 (277 US / 177 OUS)
Distribution
Worldwide Distribution: USA, Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Martinique (French), Netherlands, Norway, Palestine, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, and Yugoslavia.
Product codes and lots
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