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WHAT IS THIS?
A Urgent Field Safety Notice is communication sent by a manufacturer to users or customers in relation to a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
EVENT
| Type of Event | Urgent Field Safety Notice |
|---|---|
| Notice Reference | 40908 |
| Notice Qty | All systems not running on: V.25BK (Win2k), C.15BK or C.1523 (Windows XP), or V.60BK (Alll VG Operating Systems) |
| Notice Date | July 2025 |
| Notice Link | GE Infinia and VG Systems - Unintended Detector Motion |
| Notes/Details | None |
| Reason | GE HealthCare has become aware of a potential safety issue related to possible unintended radial detector motion, which can occur during patient setup or during a patient scan. This can occur if the system does not have the correct version of the gantry software installed. In addition to the incorrect software, several other mechanical failures would also have to be present in order for this issue to arise, including radial gear malfunctions, gear oil leaks, and brake pad misalignment. In the unlikely event that the above failures are all present at the same time and the unintended detector motion is not noticed by the technologist, the detector can slowly descend and contact the patient. |
DEVICE
| Manufacturer | GE Healthcare |
|---|---|
| Model Names | Infinia (Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 ), VG (Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH) |
| Model Numbers | N/A |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | The system is intended to be used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. |
| Serial Number(s) | All Affected per the software revision. |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
Check the gantry software version by following the instructions in Appendix A.
If the system has the correct gantry software version installed as indicated in Table 1,
you can continue to use your system.
If the software version is not one of the versions in Table 1, GE HealthCare
recommends that you discontinue use of your system and contact GE
HealthCare Service or your local Service Representative.
CONTACT INFORMATION
If you have any questions regarding this notification, please contact your GE Healthcare sales representative.
PLEASE EMAIL OR FAX THIS ACKNOWLEDGEMENT TO:
recall.40908@gehealthcare.com
