MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Reason for Recall:
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2040-2024
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