GE Healthcare Recalls Discovery ML PET/CT Systems Due to X-Ray Safety Defect
GE Healthcare is recalling 1,113 Discovery ML 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 results in continued X-ray exposure, posing a significant risk of injury (radiation exposure) to patients, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
GE Healthcare, LLC is recalling 1,113 Discovery ML PET/CT systems. 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 being conducted because the table may stop moving without stopping X-ray exposure. This defect poses a risk of unnecessary 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 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
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 →Related recalls
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