—#165013

Product

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163286
Affected lot / code info: 164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Timeline

Recall initiated: 2018-05-01
Terminated: 2020-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.