Device recall: MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT…
Class II FDA enforcement event 94557. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.
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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING started this device recall on 15 Apr 2024. The firm address in the FDA record is in Tirat Carmel. FDA put the recall in Class II. FDA event 94557 has 1 product record. The first FDA enforcement report date is 19 Jun 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 - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, NC, ND, NV, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina,…
Recalling firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, Tirat Carmel, N/A, Israel.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2040-2024 | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system). | 133 devices | Class II | Ongoing | 19 Jun 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
- 1Median of the firm: 4
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 24 Dec 2025 | GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend P | Device | Class II | 1 |
| 10 Dec 2025 | SMV DSX New Line, System, Tomography, Computed, Emission | Device | Class II | 4 |
| 12 Sep 2025 | Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging | Device | Class II | 14 |
| 20 Jun 2025 | Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system | Device | Class II | 2 |
| 18 Dec 2024 | GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Comp | Device | Class II | 13 |
| 19 Dec 2022 | GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) | Device | Class I | 6 |
Official channels
- FDA enforcement report Z-2040-2024The 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 94557. https://recallregister.com/fda/ii/94557/. 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 - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, NC, ND, NV, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina,…
- What quantity of product is in FDA event 94557?
- The FDA record gives this quantity:
133 devices
- 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.