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
|