—#180017

Product

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Serial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022

Why it was recalled

A software issue could potentially cause the stand and table movements to be blocked.

Root cause (FDA determination)

Software design

Action the firm took

On February 14, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were informed of the software error which affects the listed systems. In case of software failure, planned procedures may have to be terminated and performed on an alternative x-ray system. Customers were instructed to do the following: Issue # 1: Potential issue with the Message "Stand battery charging: DO NOT POWER OFF" on Artis zeego systems Customer Action: Please check the system messages before power off/shutdown of the system. If possible, do not switch off the system while the message "Stand battery charging: DO NOT POWER OFF" is displayed and wait until the battery has been charged or replaced. Issue # 2: Potential issue of blocked stand movements on Artis zeego systems Issue # 3: Potential issue of blocked table movements on Artis zee/ Q/ Q.zen systems with Siemens Healthineers tables For Issues #2-3, customers may continue to use their systems, but in case the problem occurs, customers are instructed to follow standard emergency procedures in place in the event of system failures. Customers are encouraged to ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Siemens will correct the software error via a software update. Siemens' service organization will contact customers to arrange a date to perform this corrective action. For an earlier appointment, please contact the firm's service organization at 1-800-888-7436.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribuiton.

Timeline

Recall initiated: 2020-02-14
Posted by FDA: 2020-03-13
Terminated: 2021-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.