Device recall: GE Healthcare Revolution EVO X-ray system
Class II FDA enforcement event 77377. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
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, LLC started this device recall on 19 May 2017. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 77377 has 16 product records. The first FDA enforcement report date is 21 Jun 2017. The record gives the status Terminated, with the termination date 29 Jul 2018.
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 - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia,…
Recalling firm
GE Healthcare, LLC, Waukesha, WI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
16 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2181-2017 | GE Healthcare Revolution EVO X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2182-2017 | GE Healthcare Optima CT660, CT680 X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2183-2017 | GE Healthcare LightSpeed VCT X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2184-2017 | GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2185-2017 | GE Healthcare Optima CT520 X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2186-2017 | GE Healthcare Optima CT540 X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2187-2017 | GE Healthcare lnnova IGS 540 ACT X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2188-2017 | GE Healthcare BrightSpeed X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2189-2017 | GE Healthcare Lightspeed RT16 X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2190-2017 | GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2191-2017 | GE Healthcare Discovery Ml DR X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2192-2017 | GE Healthcare Discovery IQ X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2193-2017 | GE Healthcare Discovery Ml X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2194-2017 | GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2195-2017 | GE Healthcare Discovery NM/CT 670 CZT X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
| Z-2196-2017 | GE Healthcare Discovery NM/CT 570c X-ray system | 10,884 | Class II | Terminated | 21 Jun 2017 |
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 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 16Median of the firm: 1
- Events of the firm on the register
- 225
Other events of the firm
Official channels
- FDA enforcement report Z-2181-2017The 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 77377. https://recallregister.com/fda/ii/77377/. 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 - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia,…
- What quantity of product is in FDA event 77377?
- The event has 16 product records. The first record gives this quantity:
10,884
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.