PlainRecordsFDA · Medical device recall
Revolution CT ES… and 1 more product
- Date
- Dec. 30, 2020
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- A potential for protocol(s) with unintended patient orientation or scan setting when using Intelligent Protocoling
- Distribution pattern
- Worldwide distribution - US Nationwide distribution including in the states of FL and TX. The countries of Belgium, France, and Spain.
2 products in this recall
Revolution CT ES…
- Product
- Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Quantity
- 2 units
- Codes and lots
- Model Number: 5995001-6; Serial Number's: REVV81900024CN (System ID:561955REV/UDI: 01008406821234711119070021REVV81900024CN) and REVV81900022CN (System ID: DPN80000/ UDI:01008406821234711119070021REVV81900022CN).
- Recall started
- Nov. 23, 2020
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Software in the Use Environment
- What the company told customers
- 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.
- Recall number
- Z-0694-2021
Revolution CT with Apex Edition CT System…
- Product
- Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Quantity
- 3 units
- 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).
- Recall started
- Nov. 23, 2020
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Software in the Use Environment
- What the company told customers
- 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.
- Recall number
- Z-0695-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0694-2021, Z-0695-2021. The agency record governs; check it and the company before acting.