—#119815

Product

ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290, K090745
Affected lot / code info: Model numbers: 10094137, 10094139, 10094141, 10280959

Why it was recalled

Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui

Root cause (FDA determination)

Software Design Change

Action the firm took

Siemens sent a Customer Safety Advisory Notice dated June 26, 2013, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were strongly recommend to carefully evaluate one of the following options before running 3D rotational acquisition programs that include real-time subtraction until a patch is installed on their system: 1) position the monitor in a way such that contrast advancement can be monitored during the fill phase on the live monitor in the control room. 2) For applications not requiring actions based on the contrast flow during the fill phase, the contrast may not need to be monitored during the fill phase. Although the monitor is not showing the expected subtraction, the acquisition is working correctly. There is no need to interrupt, but continue and finish the workflow. 3) Perform 3D rotational programs that include real time subtraction from the exam room. The display on the live monitor in the exam room is not affected by this problem. To resolve the issue, the update AX028/13/P (VC20x/VC21B), will be made available around July 2013, and scheduling an appointment for implementation of the update with Siemens Customer Service organization was recommended. If this device/equipment is no longer in theirr possession, customers were asked to forward this safety notice to the new owner and inform Siemens of the new user's identity.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution and Puerto Rico

Timeline

Recall initiated: 2013-06-26
Posted by FDA: 2013-07-22
Terminated: 2015-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119815. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.