• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Mobile X Ray Series

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Mobile X Ray Series
see related information
Date Posted November 16, 2012
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0199-2013
Recall Event ID 63597
Product Classification Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Code OXO
Product GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
Code Information part numbers: 5555000-3, 5555000-4
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue. Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard. Further questions please call (262) 513-4122.
Quantity in Commerce 364 total units installed in US
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-