Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System 의 리콜

Recall

80272

Class 2

Z-2283-2018

2018-05-01

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165013

If the c-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. as a result, the c-arm stops the movement and can drop up to 20 mm (0.8 ). under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the c-arm drop. this could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

On May 1, 2018, the firm distributed Urgent Medical Device Correction letters to its affected customers. The letter instructed customers to follow standard emergency procedures they have in place in the event of system failures. The firm recommended considering reinforcing the emergency procedures until the update has been completed. As an immediate measure, operators were instructed to avoid driving the C-arm into a fully extended longitudinal position. The firm is currently developing a solution to eliminate the root cause of the problem. The solution will be distributed to all affected customers upon completion. Customers were asked to forward the safety information to any other organizations that could be affected.