GE Healthcare Recalls Patient Steps on RFX, Legacy, and Precision 500D Systems
GE Healthcare is recalling 2,380 patient steps for RFX, Legacy, and Precision 500D systems because they may detach from the table, posing a fall 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 is classified as FDA Class II and involves a risk of injury from falls, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling the Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems. The recall involves 2,380 units, with 2,215 distributed in the United States and 165 distributed outside the US.
The recall is being issued due to reported incidents of the patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.
The affected units were distributed nationwide in the US, including DC and Puerto Rico, as well as to numerous countries outside the US. Specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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