Recall archive / FDA device enforcement

MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT... — FDA record Z-2040-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
Reason: 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.
Classification: Class II
Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Quantity: 133 devices
Agency-reported status: Ongoing
Source record identifier: Z-2040-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	MyoSPECT manufactured on or before 2024-02-13: Model H3912AA, GTIN 00195278421586 - Serial numbers 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, NGCC80078, NGCC80079, NGCC80087, NGCC80092, NGCD80105, NGCD80108, NGCB80059, NGCA80009, NGCC80086, NGCC80095, NGCA80020, NGCC80088, NGCB80055, NGCB80029, NGCB80041, NGCC80076, NGCA80016, NGCB80036, NGCC80098, NGCB80037, NGCB80046, NGCA80007, NGCC80082, NGCB80061, NGCA80002, NGCC80102, NGCB80057, NGCC80089, NGCB80030, NGCC80097, NGCA80005, NGCB80049, NGCC80101, NGCB80071, NGCA80001, NGCB80066, NGCB80065, NGCC80085, NGCC80077, NGCB80069, NGCA80014, MYGA10001, NGCC80096, NGCB80024, NGCB80047, NGCC80099, NGCB80062, NGCB80034, NGCA80008, NGCA80013, NGCB80025, NGCA80004, NGCA80019, NGCB80056, NGCB80063, NGCB80054, and NGCB80053. Model H3912BC, GTIN 00195278488619 - Serial number MYOC93001. MyoSPECT ES manufactured on or before 2024-02-15: Model H3912AB, GTIN 00195278421579 - Serial numbers NGEB81002, NGED81025, NGEB81007, NGEB81006, NGEC81019, NGEB81012, NGEB81008, NGEC81014, NGEB81005, NGEC81017, NGEC81022, NGEC81021, NGEC81020, NGEB81011, NGEB81010, NGEC81023, NGEC81024, NGEC81013, NGEB81009, NGEB81003, NGEB81004, NGEC81018, NGEC81015, and NGEC81016. Model H3912BD, GTIN 00195278488626 - Serial number MYEB94001.

Label field

Details supplied by the agency

Lot, code or applicability

MyoSPECT manufactured on or before 2024-02-13: Model H3912AA, GTIN 00195278421586 - Serial numbers 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, NGCC80078, NGCC80079, NGCC80087, NGCC80092, NGCD80105, NGCD80108, NGCB80059, NGCA80009, NGCC80086, NGCC80095, NGCA80020, NGCC80088, NGCB80055, NGCB80029, NGCB80041, NGCC80076, NGCA80016, NGCB80036, NGCC80098, NGCB80037, NGCB80046, NGCA80007, NGCC80082, NGCB80061, NGCA80002, NGCC80102, NGCB80057, NGCC80089, NGCB80030, NGCC80097, NGCA80005, NGCB80049, NGCC80101, NGCB80071, NGCA80001, NGCB80066, NGCB80065, NGCC80085, NGCC80077, NGCB80069, NGCA80014, MYGA10001, NGCC80096, NGCB80024, NGCB80047, NGCC80099, NGCB80062, NGCB80034, NGCA80008, NGCA80013, NGCB80025, NGCA80004, NGCA80019, NGCB80056, NGCB80063, NGCB80054, and NGCB80053. Model H3912BC, GTIN 00195278488619 - Serial number MYOC93001. MyoSPECT ES manufactured on or before 2024-02-15: Model H3912AB, GTIN 00195278421579 - Serial numbers NGEB81002, NGED81025, NGEB81007, NGEB81006, NGEC81019, NGEB81012, NGEB81008, NGEC81014, NGEB81005, NGEC81017, NGEC81022, NGEC81021, NGEC81020, NGEB81011, NGEB81010, NGEC81023, NGEC81024, NGEC81013, NGEB81009, NGEB81003, NGEB81004, NGEC81018, NGEC81015, and NGEC81016. Model H3912BD, GTIN 00195278488626 - Serial number MYEB94001.

Match all identifying details in the current notice. A brand name alone is not enough.

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, Belgium, Brazil, Canada, Czech Republic, Finland, France, India, Israel, Italy, Japan, Malaysia, Malta, Poland, Singapore, Spain, Taiwan, Turkey, and United Kingdom.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 19, 2024
Recall initiation date: Apr 15, 2024
Center classification date: Jun 7, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records