Z-0695-2021Class II

Revolution CT with Apex Edition CT System -

Name: Z-0695-2021 Revolution CT with Apex Edition CT System -
Creator: GE Healthcare, LLC
Published: 2020-11-23
License: https://open.fda.gov/license/

GE Healthcare / initiated 2020-11-23 / Terminated / root cause: software

FDA source

GE Healthcare, LLC began a recall of Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications on 2020-11-23. FDA classified it as Class II and gives the reason as "A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0695-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-23
Posted: 2020-12-22
Terminated: 2023-08-29
Recalling firm: GE Healthcare
Product: Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
Root cause tag: software
FDA 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 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.
Product codes and lots: Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0694-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-22
Z-0695-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-22

Product code JAK

K191777Class IIRevolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC / cleared 2019-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)