The Recall Desk
SevereFDA (Devices)·Z-1748-2019·Announced 2019-06-26

GE Healthcare Discovery IQ PET/CT Systems Recalled for X-Ray Exposure Defect

GE Healthcare is recalling 1,113 Discovery IQ PET/CT systems because the table may stop moving while X-ray exposure continues.

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 is classified as FDA Class II and involves a risk of unintended radiation exposure, which aligns with the rubric criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

GE Healthcare, LLC is recalling 1,113 Discovery IQ PET/CT systems distributed nationwide. These 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.

The recall is due to a defect where the patient table may stop moving without stopping the X-ray exposure. This malfunction could result in patients receiving unintended radiation exposure.

Healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The source text does not specify reported injuries or illnesses.

The recalled product

Product
Discovery IQ 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 IQ

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 →