GE Healthcare Recalls Lightspeed 16 CT Scanners Due to Power Supply Expulsion Risk
GE Healthcare is recalling 416 Lightspeed 16 CT scanners worldwide because the power supply may be expelled from the unit.
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 (medical device) where the power supply may be expelled, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 416 units of the Lightspeed 16 CT scanner. The recall is due to a potential defect where the power supply may be expelled from the scanner. The affected devices are distributed in the United States and in numerous countries including Argentina, Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Germany, Hungary, India, Indonesia, Israel, Italy, Japan, Republic of Korea, Mexico, Norway, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The recall notice identifies the hazard as the potential for expulsion of the power supply. The source text also references the Discovery ST PET CT and Discovery LS PET CT scanners in the context of this specific hazard description. No specific dates, lot numbers, or injury reports are provided in the source text.
Healthcare facilities should contact GE Healthcare for instructions on how to address this issue. Consumers and patients should consult with their healthcare providers regarding the status of their imaging equipment.
The recalled product
- Product
- Lightspeed 16 CT
- Manufacturer
- GE Healthcare
- Category
- Medical Device — CT Scanner
- Affected units
- 416
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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