MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
This recall is currently active, issued June 7, 2024. It was issued by Ge Medical Systems Israel, Functional Imaging 4, Hayozma St Tirat Carmel Israel.
- Recall Initiated
- April 15, 2024
- Posted
- June 7, 2024
- Recall Number
- Z-2040-2024
- Quantity
- 133 devices
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
The recalling firm issued letters on and dated 4/15/2024 via FedEx informing the consignee of the safety issue and actions to be taken by the customer/user. The actions state the consignee can continue to use the system but until GE HealthCare implements the correction for this potential issue on the affected device and before conducting any servicing activities that involve movement of the covers, GE HealthCare Service should be contacted for guidance. An acknowledgement form was enclosed for completion and return. The letter contained an embedded photograph of the device showing where to find the manufacturing date to determine if it is an affected device. The letter also informs the consignee they will be contacted by a GE HealthCare representative to arrange for the correction.