GE Healthcare Recalls PET Discovery LS Scanners Due to Power Supply Risk
GE Healthcare is recalling six PET Discovery LS scanners because the power supply may be expelled, posing a safety risk.
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 involves a risk-of-harm product (potential power supply expulsion) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare is recalling six units of the PET Discovery LS scanner. The recall is due to a potential for the expulsion of the power supply on the device.
The affected units were distributed worldwide, including in the United States and various international locations. The source text does not specify the number of injuries or illnesses associated with this defect.
Consumers and healthcare facilities with these devices should contact GE Healthcare for further instructions on how to address the potential power supply issue.
The recalled product
- Product
- PET Discovery LS
- Manufacturer
- GE Healthcare
- Affected units
- 6
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare 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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