GE PET Discovery 610 and 710 Recalled for Image Series UID Conflict
GE Healthcare is recalling PET scanners because a software issue may cause different image series to share the same ID, potentially leading to incorrect image display.
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 3/5 (High).
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, and the hazard involves a risk of harm (incorrect image display) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling 28 units of the GE PET Discovery 610 and PET Discovery 710 scanners. These devices are intended for head and whole-body attenuation-corrected Positron Emission Tomography (PET) imaging. The recall involves a potential safety issue related to the DMPR function and Screen Saved Images, which may generate the same Series UID for different image series.
The hazard is that some Picture Archiving and Communication Systems (PACS) may combine series under a patient using only the Series UID. If this occurs, it could result in the incorrect display of patient images. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries.
No specific instructions for consumers are provided in the source text, but the issue involves medical imaging data integrity. Healthcare facilities should be aware of the potential for image series combination due to the shared Series UID.
The recalled product
- Product
- GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
- Manufacturer
- GE Healthcare, LLC
Distribution
Part of a larger recall action
This product is one of 2 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.
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