Date Initiated by Firm | June 14, 2021 |
Create Date | June 25, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1900-2021 |
Recall Event ID |
88116 |
510(K)Number | K131576 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Revolution EVO, Optima CT660, Optima CT680 CT Systems. |
Code Information |
Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | 800-437-1171 |
Manufacturer Reason for Recall | Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
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FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | GE Healthcare will send an Important Electronic Product Radiation Warning letter to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take to prevent this issue. |
Quantity in Commerce | 3665 |
Distribution | 3,665 (US = 956; OUS = 2,709) |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JAK
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