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U.S. Department of Health and Human Services

Class 2 Device Recall BrivoXR285amx

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  Class 2 Device Recall BrivoXR285amx see related information
Date Initiated by Firm December 19, 2014
Date Posted April 27, 2015
Recall Status1 Terminated 3 on April 29, 2015
Recall Number Z-1405-2015
Recall Event ID 70924
510(K)Number K103476  
Product Classification System, x-ray, mobile - Product Code IZL
Product GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
Code Information BrivoXR285amx - PN 5555000, 5555000-2
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
Quantity in Commerce 6 units US
Distribution US Distribution to the states of: AZ, FL, GA, MO and WI.
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 = IZL and Original Applicant = GE MEDICAL SYSTEMS, LLC
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