FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0695-2021
- Recalling firm
- GE Healthcare, LLC
- Product
- Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Status
- Terminated
- Initiated
- 2020-11-23
- Posted
- not on file
- Terminated
- 2023-08-29
- 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 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
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
- Lot, serial or model codes
- Model Number: 5995000-5; Serial Number's: REVVX1700078CN (System ID: 713MMREVCT/UDI: 01008406821185521117070021REVVX1700078CN) , 00000440315CN0 (System ID: 220078CT04), and REVVX1800040CN (System ID: M2322265/UDI: 01008406821185521118030021REVVX1800040CN).
- 510(k) numbers
- ["K191777"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28