GE 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…
Read the official notice →- Date
- 2026-01-28
- Country
- United States
- Brand
- Ge Medical Systems Israel, Functional Imaging
- Product
- GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm -…
- Classification
- Class II
- Units
- Worldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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USGE 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
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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
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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
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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)…
- 2024-06-19
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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…
FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - 2023-02-15
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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.
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Other drugs & medical recalls in the United States
- 2026-01-28
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Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication…
- US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Philippines.Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system; Software Version Number: R3.1;
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.International distribution in the countries of AE, AR, AT, AZ, BE, BG, BH, BR,…Official notice → - US
ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
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RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025,…
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