MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (
Summary
The FDA issued a Class II for MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912A by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. 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 cau.
Details
Source
Device Recall
External ID
Z-2040-2024
Action Date
2024-06-19
Status
Ongoing
Category
device
Product Description
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).
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.
Quantity Affected: 133 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-15
Company
Tirat Carmel, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING have FDA actions?
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2040-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29