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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: MyoSPECT Systems Recalled Due to Risk of Falling Lead Covers and Injury

Agency Publication Date: June 7, 2024
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Summary

GE Medical Systems Israel is recalling 133 MyoSPECT and MyoSPECT ES cardiac imaging systems because the service handles for internal lead covers can loosen or release. If a handle fails, the heavy lead cover could drop unexpectedly while the machine is being serviced. This recall affects MyoSPECT models H3912AA, H3912B, H3912BC and MyoSPECT ES models H3912AB and H3912BD manufactured on or before mid-February 2024. Consumers should contact the manufacturer or their healthcare provider for further instructions regarding this safety issue.

Risk

The internal lead covers are heavy and rely on service handles that may loosen over time; if a handle releases, the cover can fall, potentially causing impact or crushing injuries to service personnel working on the equipment.

What You Should Do

  1. Identify if your facility uses a MyoSPECT or MyoSPECT ES system by checking the model and serial numbers on the device label. Affected MyoSPECT units (Model H3912AA) include serial numbers such as NGCC80094, NGCB80033, and NGCA80017; Model H3912BC includes serial number MYOC93001.
  2. Check MyoSPECT ES units for Model H3912AB (serial numbers including NGEB81002, NGED81025, and NGEC81019) and Model H3912BD (serial number MYEB94001).
  3. Verify the manufacture date on your device label; affected units were manufactured on or before February 13, 2024 (MyoSPECT) or February 15, 2024 (MyoSPECT ES).
  4. Contact GE Medical Systems or your healthcare facility's biomedical engineering department to confirm if your specific unit has been inspected or requires service for the lead cover handles.
  5. Ensure that only authorized and informed service personnel attempt to open or maintain the internal lead covers until the issue is resolved.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated contact via letter to advise on the service handle issue.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MyoSPECT System (Model H3912AA)
Model / REF:
H3912AA
UPC Codes:
00195278421586
Lot Numbers (108):
NGCC80094
NGCB80033
NGCB80044
NGCB80045
NGCA80017
NGCB80039
NGCA80006
NGCA80011
NGCA80003
NGCA80012
NGCB80052
NGCB80060
NGCC80074
NGCC80081
NGCB80038
NGCD80107
NGCB80070
NGCC80093
NGCD80106
NGCB80026
NGCB80050
NGCB80058
NGCC80084
NGCB80027
NGCB80072
NGCB80032
NGCB80031
NGCC80080
NGCB80067
NGCA80021
NGCA80010
NGCA80015
NGCB80043
NGCC80090
NGCC80091
NGCD80104
NGCB80028
NGCB80022
NGCB80023
NGCB80048
NGCB80035
NGCD80103
NGCC80100
NGCC80083
NGCB80042
NGCC80075
NGCB80068
NGCB80040
NGCB80051
NGCB80064
Date Ranges: Manufactured on or before 2024-02-13
Product: MyoSPECT System (Model H3912BC)
Model / REF:
H3912BC
UPC Codes:
00195278488619
Lot Numbers:
MYOC93001
Date Ranges: Manufactured on or before 2024-02-13
Product: MyoSPECT ES System (Model H3912AB)
Model / REF:
H3912AB
UPC Codes:
00195278421579
Lot Numbers:
NGEB81002
NGED81025
NGEB81007
NGEB81006
NGEC81019
NGEB81012
NGEB81008
NGEC81014
NGEB81005
NGEC81017
NGEC81022
NGEC81021
NGEC81020
NGEB81011
NGEB81010
NGEC81023
NGEC81024
NGEC81013
NGEB81009
NGEB81003
NGEB81004
NGEC81018
NGEC81015
NGEC81016
Date Ranges: Manufactured on or before 2024-02-15
Product: MyoSPECT ES System (Model H3912BD)
Model / REF:
H3912BD
UPC Codes:
00195278488626
Lot Numbers:
MYEB94001
Date Ranges: Manufactured on or before 2024-02-15

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94557
Status: Active
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Sold By: Authorized GE Healthcare distributors; Direct medical equipment sales
Manufactured In: Israel
Units Affected: 133 devices
Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.