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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 Device Recall Fluorostar 7900 Mobile Fluoroscopy System see related information
Date Initiated by Firm February 19, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on July 22, 2011
Recall Number Z-1155-2009
Recall Event ID 51856
510(K)Number K043076  
Product Classification Image-Intensified Fluoroscopic X-Ray System - 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 UT 84116-2862
For Additional Information Contact
801-517-6717
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
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