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U.S. Department of Health and Human Services

Class 2 Device Recall Precision 500D

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  Class 2 Device Recall Precision 500D see related information
Date Initiated by Firm May 02, 2013
Date Posted August 20, 2013
Recall Status1 Terminated 3 on November 26, 2013
Recall Number Z-1989-2013
Recall Event ID 65862
510(K)Number K011624  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product GE Healthcare, Precision 500D

Product Usage:
The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Code Information FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial 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Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and
FDA Determined
Cause 2
Device Design
Action GE Healthcare "Urgent Medical Device Correction" letter dated May 1, 2013 to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter informed customers that GE Healthcare will correct all affected systems at no cost. A GE Healthcare service representative will contact you to arrange for this correction. For questions or concerns regarding this notification call: US 800-437-1171, Japan: 0120-055-919.
Quantity in Commerce 445 (421 US, 24 OUS)
Distribution Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
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 MEDICAL SYSTEMS