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U.S. Department of Health and Human Services

Class 2 Device Recall Fluorostar 7900 Mobile Fluoroscopy System

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 Class 2 Recall
Fluorostar 7900 Mobile Fluoroscopy System
see related information
Date Posted September 24, 2009
Recall Status1 Open
Recall Number Z-1155-2009
Recall Event ID 51856
Premarket Notification
510(K) Number
K043076 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
Code Information n/a
Recalling Firm/
Manufacturer
Ge Healthcare
384 Wright Brothers Dr
Salt Lake City, Utah 84116-2862
Manufacturer Reason
for Recall
The alarm timer is reset after each exposure and therefore never reaches the five minute alarm state unless one exposure exceeds 5 minutes in duration.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action GE Healthcare sent a customer notification out to all sites that have potentially affected systems. GEHC Surgery will also install a software correction into the affected systems in order to resolve this issue at no charge to the customer. Until the GEHC OEC Fluorostar 7900 has received the corrective software installed, they are encouraging facilities to exercise caution in monitoring the amount of cumulative fluoroscopy time when the affected system is in use.
Quantity in Commerce 554 units
Distribution Worldwide 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.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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