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U.S. Department of Health and Human Services

Class 2 Device Recall AMX Navigate Mobile XRay System

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  Class 2 Device Recall AMX Navigate Mobile XRay System see related information
Date Initiated by Firm June 24, 2021
Date Posted September 29, 2021
Recall Status1 Terminated 3 on June 14, 2023
Recall Number Z-2590-2021
Recall Event ID 88601
510(K)Number K210982  
Product Classification System, x-ray, mobile - Product Code IZL
Product AMX Navigate Mobile X-Ray System
Code Information AMXNV2000001WK, AMXNV2000002WK, DF2401600003WK
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
FDA Determined
Cause 2		 Process control
Action On June 24, 2021 the firm contacted the facilities that received the device via email. An AMX Navigate system was provided to 3 healthcare facilities for evaluation under an agreement with GE Healthcare. While at the healthcare facilities, these systems remained under the ownership of GE Healthcare. After one of the healthcare facilities alerted GE Healthcare to a potential issue with its system, GE Healthcare removed the system from the 3 healthcare facilities in order to perform a detailed engineering analysis as part of its root cause investigation. These 3 systems have not been returned to the healthcare facilities and remain in GE Healthcare s possession.
Quantity in Commerce 3 units
Distribution Domestic Distribution Only
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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