Device recall: GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Class II FDA enforcement event 95704. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation…
Class II, in the words of FDA
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
GE Healthcare (China) Co., Ltd. started this device recall on 5 Nov 2024. The firm address in the FDA record is in Beijing. FDA put the recall in Class II. FDA event 95704 has 17 product records. The first FDA enforcement report date is 11 Dec 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution.
Recalling firm
GE Healthcare (China) Co., Ltd., Beijing, China.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
17 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0600-2025 | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: | 11 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0601-2025 | GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems | 11 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0602-2025 | GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system | 8 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0603-2025 | GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems | 5 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0604-2025 | GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems | 10 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0605-2025 | GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system | 16 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0606-2025 | GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system | 4 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0607-2025 | GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system | 4 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0608-2025 | GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system | 2 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0609-2025 | GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system | 3 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0610-2025 | GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system | 72 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0611-2025 | GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system | 3 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0612-2025 | GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system | 10 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0613-2025 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system | 5 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0614-2025 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite Select; X-ray/computed tomography system | 4 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0615-2025 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT | 3 units | Class II | Ongoing | 11 Dec 2024 |
| Z-0616-2025 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD | 1 unit | Class II | Ongoing | 11 Dec 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 17Median of the firm: 5
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Jan 2025 | SIGNA Creator, SIGNA Explorer, NMRI systems | Device | Class II | 5 |
| 24 Oct 2024 | GE Proteus XR/A radiographic system | Device | Class II | 1 |
| 12 Jul 2024 | GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 23735 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0600-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 95704. https://recallregister.com/fda/ii/95704/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution.
- What quantity of product is in FDA event 95704?
- The event has 17 product records. The first record gives this quantity:
11 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.