—#183198

Product

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226

Why it was recalled

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

Siemens iMedical Solutions USA Inc. issued A Customer Safety Advisory Notice dated 8/03/20 affected customers via AX047/20/S. Letter states reason for recall, health risk and action to take:Siemens strongly recommends paying close attention during system movements to avoid any collision and to establish appropriate emergency procedures until the corrective action has been performed. In case of collision, it is recommended to check the system for any damages before continuing with treatment. If any device part continues to move although that movement was not released, a potential malfunction may be present. In this case, the system must be shut down and Siemens Healthineers service organization must be informed. Our service organization will contact you to schedule an appointment to perform inspection of the affected system by Siemens service engineer, and, where necessary, recover the individual room configuration data setings This correction will be implemented via Update Instruction AX046/20/S. Following the inspection by a service engineer the individual room configuration data settings will be available again. Please feel free to contact our service organization at 1-800-888-7436 for an earlier appointment. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.

Recalling firm

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

Distribution

Distribution pattern: US Natonwide distribution.

Timeline

Recall initiated: 2020-08-03
Terminated: 2021-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.