Device recall: Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Class II FDA enforcement event 80484. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
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 24 May 2018. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 80484 has 10 product records. The first FDA enforcement report date is 8 Aug 2018. The record gives the status Terminated, with the termination date 8 Feb 2019.
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.
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
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: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2578-2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | 42 devices total | Class II | Terminated | 8 Aug 2018 |
| Z-2579-2018 | Discovery MI Digital Ready | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2580-2018 | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2581-2018 | Discovery RT labeled as: a. MID BJG; b. HVY BJG | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2582-2018 | Revolution CT 160 1.5D STD WAUK | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2583-2018 | CT Goldseal Optima CT 600 | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2584-2018 | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK. | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2585-2018 | Optima CT 520 | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2586-2018 | Optima CT 540 | 42 units total | Class II | Terminated | 8 Aug 2018 |
| Z-2587-2018 | CT Goldseal BrightSpeed 16 PWR TIO 2 YR | 42 units total | Class II | Terminated | 8 Aug 2018 |
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 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 10Median of the firm: 1
- Events of the firm on the register
- 225
Other events of the firm
Official channels
- FDA enforcement report Z-2578-2018The 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 80484. https://recallregister.com/fda/ii/80484/. 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:
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
- What quantity of product is in FDA event 80484?
- The event has 10 product records. The first record gives this quantity:
42 devices total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.