GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Medical Device Recall in 2024 - (Recall #: 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).

Class II

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.

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.

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.

Voluntary: Firm initiated