The Recall Desk
HighFDA (Devices)·Z-0981-2014·Announced 2014-02-26

GE Healthcare Recalls PET Discovery Systems Due to Scatter Overcorrection

GE Healthcare is recalling PET Discovery 600, 610, 690, and 710 systems due to a potential safety issue with the List Mode Replay feature causing scatter overcorrection.

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, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a potential safety issue (scatter overcorrection) without reported injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling specific models of PET Discovery systems, including the Discovery 600, 610, 690, and 710. The recall is due to a potential safety issue associated with the List Mode Replay feature of these devices.

The issue involves scatter overcorrection, which may affect the accuracy of the imaging data produced by the affected systems. The recall covers 376 units distributed worldwide, including 101 units in the United States and 275 units in other countries.

Healthcare facilities using these systems should contact GE Healthcare for further instructions on how to address the issue. The source text does not specify a deadline for the recall or specific corrective actions beyond the identification of the safety issue.

The recalled product

Product
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy b
Manufacturer
GE Healthcare, LLC
Category
Medical Device — PET Imaging Systems
Hazard

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)

  • A5330718

Distribution

Distributed in 30 states:

Related recalls

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