GE Healthcare Recalls Nuclear Medicine Systems Due to Collimator Detachment Risk
GE Healthcare is recalling 472 nuclear medicine systems worldwide because a collimator may fall off during rotation. No injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (falling heavy component) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed harm.
Plain-English summary
GE Healthcare is recalling 472 units of Millennium VG, Discovery VH, and VariCam Nuclear Medicine systems, all configurations. The recall covers 127 units in the United States and 345 units outside the US, distributed worldwide across numerous countries.
The recall was initiated after GE Healthcare became aware of a potential safety issue where a collimator fell off a VG system during a Quality Control check while the detectors were rotating. The source text states that no injuries have been reported to date.
Affected units are identified by specific serial numbers and system IDs listed in the official recall documentation. Healthcare facilities should verify their equipment against the provided list of serial numbers and contact GE Healthcare for further instructions on corrective actions.
The recalled product
- Product
- GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using…
- Manufacturer
- GE Healthcare
Distribution
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