Drugs & medicalClass II

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…

Read the official notice →
Date
2025-10-29
Country
United States
Brand
Ge Medical Systems Israel, Functional Imaging
Product
Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Classification
Class II
Units
Worldwide
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-01-28
  2. US
    Drugs & medicalClass II

    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…

    FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwide distribution. US Nationwide, Argentina, Australia, Belgium, Brazil,…Official notice →
  3. 2026-01-21
  4. US
    Drugs & medicalClass II

    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 →
  5. 2025-07-16
  6. US
    Drugs & medicalClass II

    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 →
  7. 2025-01-22
  8. US
    Drugs & medicalClass II

    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)…

    FDA · DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGWorldwideOfficial notice →
  9. 2024-06-19
  10. US
    Drugs & medicalClass II

    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 →
  11. 2023-02-15
  12. US
    Drugs & medicalClass I

    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 →
All 7 Ge Medical Systems Israel, Functional Imaging recalls →

Other drugs & medical recalls in the United States

  1. 2025-11-05
  2. US
    Drugs & medicalClass II

    Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging,…

    Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

    FDA · DrugAmerisource Health Services LLCNationwide within the United StatesOfficial notice →
  3. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…

    CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

    FDA · DrugBreckenridge Pharmaceutical, Inc.U.S. NationwideOfficial notice →
  4. US
    Drugs & medicalClass II

    Samsung Bioepis Co., Ltd. recalls HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC,…

    Lack of Assurance of Sterility.

    FDA · DrugSamsung Bioepis Co., Ltd.Distributed only to one warehouse in NJ. with no further distributionOfficial notice →
  5. 2025-10-29
  6. US
    Drugs & medicalClass II

    LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft; REF: AG1015;

    The device was incorrectly packed in the wrong size labeled outer packaging.

    FDA · DeviceLeMaitre Vascular, Inc.US distribution to the state of: AROfficial notice →
  7. US
    Drugs & medicalClass II

    HeartSine Technologies Ltd recalls HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact.

    FDA · DeviceHeartSine Technologies LtdUS Nationwide distribution. Worldwide distribution to Argentina, Australia,…Official notice →
  8. US
    Drugs & medicalClass II

    SEDECAL SA recalls MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system

    Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible…

    FDA · DeviceSEDECAL SAUS: CA, IL, and NJOfficial notice →
See all drugs & medical recalls →