GE Healthcare Recalls Proteus XR/a Radiographic Systems for Audible Indicator Failure
GE Healthcare is recalling Proteus XR/a radiographic systems because they may fail to provide an audible indication when an exposure is complete.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
GE Healthcare, LLC is recalling the Proteus XR/a (SlOK : K993090) stationary radiographic system. The recall involves 647 units in the United States and 167 units outside the United States, with distribution worldwide and nationwide in the US.
The recall is due to a defect where the system may intermittently fail to provide an audible exposure indication upon the completion of an exposure. This issue is associated with specific console part numbers, including 5441870, 5462233, 5462233-R, 5761170, and 5462233-H.
The FDA has classified this as a Class II recall. Users of these systems should contact GE Healthcare for further instructions regarding the defect.
The recalled product
- Product
- Proteus XR/a (SlOK : K993090)
- Manufacturer
- GE Healthcare, LLC
- Hazard
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 (4)
- console part number 5441870) and (console spare part numbers 5462233
- 5462233-R
- 5761170
- 5462233-H)
Distribution
Distributed nationwide across the United States.
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