The Recall Desk
HighFDA (Devices)·Z-0703-2019·Announced 2019-01-16

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.

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: 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.

See all 2 products in this recall →