Nuclear medicine systems may show unintended radial detector motion during scans
Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: unintended motion of a detector around a patient, which the manufacturer says may cause life-threatening injury, with no injury reported in the source.
Plain-English summary
The Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH Nuclear Medicine Systems are being recalled, identified by the serial numbers listed in the recall notice. The action covers 21 units.
According to the manufacturer, unintended radial detector motion may occur during patient setup or during a patient scan if the system does not have the correct version of gantry software installed, and unintended detector motion may result in life-threatening injury. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: Millennium VG 1074
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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