The Recall Desk

FDA (Devices) recall action 69570

GE Healthcare, LLC recalled 6 products on 2014-11-19

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2014-11-19
Critical
0
Units
3,410

Why these products were recalled

GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.

GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2014-11-19

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 147 Discovery NM 630 nuclear imaging systems to update maintenance procedures and prevent loose fasteners from causing parts to fall on patients.

    Product
    Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, locali
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-11-19

    GE Healthcare Infinia Nuclear Medicine Systems Recalled for Loose Fasteners

    GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-11-19

    GE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices

    GE Healthcare is recalling 478 nuclear medicine imaging devices because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tra
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-11-19

    GE Optima NM/CT 640 Recalled for Loose Camera Fasteners

    GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera to fall onto a patient during a scan.

    Product
    Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system u
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-11-19

    GE Healthcare Recalls Brivo NM615 Nuclear Imaging Systems Due to Loose Fasteners

    GE Healthcare is recalling 22 Brivo NM615 nuclear imaging systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system inten
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-11-19

    GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners

    GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.

    Product
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare profession
    Category
    Distribution
    2 states