—#178168

Product

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Model Number: 10094142 Serial Number: 140422, 140423, 140430 Software Version: VC21C

Why it was recalled

In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.

Root cause (FDA determination)

Software design

Action the firm took

On November 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE CORRECTION Dear Customer, This letter is to inform you of a corrective action that will be performed to prevent a possible hazard to patients, operators, or other persons and equipment due to a potential software error in software version VC21C and serial numbers 140422, 140423 or 140430. Artis zee systems with software version VC21C and serial # 140422, 140423 or 140430 This potential software issue has no influence on the previous treatment/diagnosis of patients. However, in case of software failure, planned procedures may have to be terminated and perfomed on an alternative x-ray system. What is the underlying issue requiring corrective action and when does the issue occur? In affected Artis systems, the movement of the floating tabletop may become blocked after a collision sensor has been activated during system movements. The collision supervision will display a user message on the monitor. What is the impact on system operation and what are the potential risks? During normal operation, activation of a collision sensor will cause a block of any system movements but moving the floating tabletop is still possible. In affected Artis systems, the movement of the floating tabletop is blocked and could result in a delay or interruption of a procedure. We do not consider it necessary to re-examine any patients in this case as this possible software error had no influence on treatment of patients. How was the issue detected, what is the cause, and what action will be taken? The issue was detected during regular field monitoring. The root cause for the blocked tabletop movement (horizontally and vertically) is a software error of the stand control unit. By using the safety override function and moving out of the collision zone, the system movement can be resumed. In safety override mode you may try to resolve a coll

Recalling firm

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

Distribution

Distribution pattern: US: WA and TX International: Denmark

Timeline

Recall initiated: 2019-11-14
Terminated: 2020-05-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178168. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.