Device recall: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission…
Class II FDA enforcement event 88208. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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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 30 Jun 2021. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 88208 has 3 product records. The first FDA enforcement report date is 14 Jul 2021. 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.
US
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
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2021-2021 | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart,… | Class II | Ongoing | 14 Jul 2021 | |
| Z-2022-2021 | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart,… | Class II | Ongoing | 14 Jul 2021 | |
| Z-2023-2021 | The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may… | Class II | Ongoing | 14 Jul 2021 |
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 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 225
Other events of the firm
Official channels
- FDA enforcement report Z-2021-2021The 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.
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Cite this page
Recall Register. FDA enforcement event 88208. https://recallregister.com/fda/ii/88208/. 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:
US
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.
- How many FDA recalls does GE Healthcare, LLC have?
- GE Healthcare, LLC is the recalling firm in 225 enforcement events on this register. This event is 1 of them.