| ||Class 2 Recall|
GE Healthcare, Innova 3100 and Innova 4100 systems
||June 28, 2013
||Terminated on March 13, 2014
|Recall Event ID
Interventional Fluoroscopic X-Ray System - Product Code OWB
||GE Healthcare, Innova 3100 and Innova 4100 systems.
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
|GE Healthcare reported a potential safety issue
due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
|DESIGN: Software Design
||A Customer Letter was not originally sent. GE Healthcare has retrospectively re-assessed the reportability of the field action and has determined that the action should be reported to the FDA.
GE Healthcare has already updated all of the affected Innova 3100 and Innova 4100 systems that were distributed.
As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests have recorded the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion have been retained per their processes and procedures.
If you have any questions, please call 262-548-2757.
For questions regarding this recall call 262-513-4122.
|Quantity in Commerce
||Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.
|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.
510(K)s with Product Code = OWB and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS SCS
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS, LLC