GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac…
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…
Read the official notice →- Date
- 2024-06-19
- Country
- United States
- Brand
- Ge Medical Systems Israel, Functional Imaging
- Product
- MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ge Medical Systems Israel, Functional Imaging recalls
- 2026-01-28
USGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni…
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…Official notice →- 2026-01-21
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGUS, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France,…Official notice → - 2025-10-29
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in…
- 2025-07-16
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide - US Nationwide distribution.Official notice → - 2025-01-22
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography,…
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices)…
- 2023-02-15
- US
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8…
A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US nationwide including Puerto Rico, Algeria,…Official notice →
Other drugs & medical recalls in the United States
- 2024-06-19
- US
B Braun Medical Inc recalls Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
FDA · DeviceB Braun Medical IncWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Rygel Advanced Machines d/b/a Omtech Laser recalls OMTech Desktop Laser Engraver
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
- US
Canon Medical System, USA, INC. recalls MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage…
The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of…
FDA · DeviceCanon Medical System, USA, INC.US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ,…Official notice → - US
Mckesson Medical-Surgical Inc. Corporate Office recalls Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS…
Quarantined product was inadvertently distributed
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the state of NJ.Official notice → - US
Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice → - US
Avanos Medical, Inc. recalls NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product Code…
The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Australia, New…Official notice →