GE Healthcare Recalls Optima PET/CT Systems Due to X-Ray Exposure Hazard
GE Healthcare is recalling 1,113 Optima PET/CT 560 and 560FX systems because the table may stop moving while X-ray exposure continues.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 the hazard involves unintended X-ray exposure, which constitutes a significant injury risk.
Plain-English summary
GE Healthcare, LLC is recalling 1,113 Optima PET/CT 560 and 560FX systems. These medical devices 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 without stopping X-ray exposure. This malfunction creates a risk of unintended radiation exposure to patients during imaging procedures.
The affected units were distributed nationwide. Healthcare facilities and users of these systems should contact GE Healthcare for further instructions on how to address the defect.
The recalled product
- Product
- Optima PET/CT 560, 560FX 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
- Hazard
- 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 (2)
- CT 560
- 560FX
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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