GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Collimator Locking Hazard
GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
GE Healthcare, LLC is recalling 339 units of the Discover VH/Millennium VG Nuclear Medicine Imaging System. These systems were distributed worldwide. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a potential hazardous situation involving the collimator locking handle. If the handle is not properly placed in the lock position, the warning circuit may fail to detect that the collimator is unlocked. This failure can occur specifically when a patient is in close proximity to the collimator during a clinical scan.
Healthcare facilities and users of these systems should contact GE Healthcare for instructions on how to address the defect. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Discover VH/Millennium VG Nuclear Medicine Imaging System
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 339
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC 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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