Date Initiated by Firm | November 23, 2020 |
Create Date | December 22, 2020 |
Recall Status1 |
Terminated 3 on August 29, 2023 |
Recall Number | Z-0695-2021 |
Recall Event ID |
86932 |
510(K)Number | K191777 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. |
Code Information |
Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN). |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | 1800-437-1171 |
Manufacturer Reason for Recall | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
FDA Determined Cause 2 | Software in the Use Environment |
Action | A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 11/23/2020 via a parcel service. The letter instructs the consignee that they can continue to use their Revolution CT ES or Revolution CT with Apex Edition. They are asked to ensure that users review all protocols recommended by the system. It is important to confirm that the proper protocol is selected, and the patient orientation properly
matches the protocol orientation picture in the Scan Settings window. If using the Intelligent Protocoling Autoselect preference, and more than one protocol is shown in
the Selected Protocols window, the users are asked to carefully review these protocols to only select the
appropriate one. The firm mentions that GE Healthcare will correct all affected products at no cost to the consignee. A GE Healthcare representative will contact the consignee to arrange for the correction. If the consignee has any questions, they are to contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. |
Quantity in Commerce | 3 units |
Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain. |
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 = JAK
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