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 |
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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.
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510(K) Database | 510(K)s with Product Code = IZL
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