GE Healthcare Radiographic Systems Recalled for Safety Mechanism Failure
GE Healthcare is recalling Precision 500D and Advantx Legacy systems because a safety mechanism may fail to engage, posing a risk of injury from falling equipment.
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 where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 4,053 units of Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. These devices are used for diagnostic imaging and support patients during radiological procedures.
The recall is due to a defect in the SFD/IDD safety mechanism, which may not engage properly at the lower range of travel. This mechanism is designed to hold the equipment and prevent it from falling if a counterweight cable fails. A fall of the SFD/IDD could result in injury to a patient or operator.
The affected units were distributed worldwide, including in the United States and numerous international countries. Users should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or…
- Manufacturer
- GE Healthcare
- 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 (1)
- Mfg Lot or Serial # Model
Distribution
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