Recall Z-0695-2021 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
| Date | Nov 23, 2020 |
| Status | Terminated |
| Reason | A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling |
| Root cause | 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 |
| Quantity | 3 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC, Jul 26, 2019 |