The Recall Desk
SevereFDA (Devices)·Z-1750-2019·Announced 2019-06-26

GE Healthcare Recalls Discovery ML DR PET/CT Systems Due to Table Stop Defect

GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to unintended radiation exposure, fitting the criteria for a Severe recall (Score 4) due to the risk of significant injury.

Plain-English summary

GE Healthcare, LLC is recalling 1,113 Discovery ML DR Positron Emission Tomography (PET) and Computed Tomography (CT) systems. These systems are intended for head and whole-body attenuation-corrected PET imaging and localization of emission activity in patient anatomy.

The recall is being conducted because the table on these systems may stop moving without stopping the X-ray exposure. This defect could result in unintended radiation exposure to patients.

The affected units were distributed nationwide. Healthcare facilities should contact GE Healthcare for further instructions on how to address this issue.

The recalled product

Product
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
Manufacturer
GE Healthcare, LLC
Affected units
1,113

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)

  • Discovery Ml DR

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →