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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.

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 Class 2 Recall
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X.
see related information
Date Posted October 17, 2013
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0012-2014
Recall Event ID 66277
Premarket Notification
510(K) Numbers
K011624  K081091  K760466  K801320  K973039 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
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Not Available 416284LS16 Not Available 506648L9A Not Available 514934BRAD3
Recalling Firm/
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON p
FDA Determined
Cause 2
TRAINING: Employee Error
Action GE Healthcare sent an "Urgent Medical Device Correction" letter dated August 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to inspect your power assist handle for either of the two conditions listed below. Immediately contact your local GE Healthcare Service Representative if any issue is found. 1. If you observe that the power assist handle plastic grip is loose relative to the mount, discontinue use. 2. If plastic grip is secure, but you observe erratic performance, (power assist unresponsive, drifting of spotfilm device with no command, or lock release always ON), you may continue to use the device with care. Use all safety precautions relative to application of the myelographic stop and the inhibit, table horizontal stop OFF. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 055 919 For other countries, please contact your local GE Healthcare Service Representative .
Quantity in Commerce 810 (783 US, 27 OUS)
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 HEALTHCARE
510(K)s with Product Code = JAA and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = JAA and Original Applicant = GENERAL ELECTRIC CO.