ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angio

FDA device recall Z-0400-2021 · posted 2020-11-04 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.

Action taken

A letter was sent to all affected customers on 09/18/2020 stating the following: Users are strongly recommended to not start releasing the x-ray for DSA (e.g. by pressing the pedal of the foot switch) until the system reaches the target position and has stopped moving. Siemens will correct this issue with a software patch via Update Instruction AX061/20/S. Siemens service organization will contact their affected customers to arrange a date to update the software. Customers can contact Siemens service organization for an earlier appointment by calling 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Customers are instructed to review the urgent medical device correction letter, and confirm acknowledgement of the information and instructions outlined in the letter. Customers are also instructed to promptly notify and instruct accordingly all of their staff at their respective organizations who need to be aware of this notice and comply with the recommendations therein. If customers have further distributed the device, they are instructed to identify those customers and notify them of this product recall immediately. Siemens also requests that customers inform Siemens who the new owners of the device are (when applicable).

Root cause

Software design

Status

Terminated

Product code

OWB

Quantity affected

100 distributed worldwide. 31 distributed nationwide in U.S.

Distribution

US Nationwide distribution.

Date initiated

2020-09-18

Date posted

2020-11-04

Date terminated

2021-07-23

Location

Malvern, PA

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