Z-1496-2020Class II

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No...

Name: Z-1496-2020 Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-02-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-02-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2020-02-14. FDA classified it as Class II and gives the reason as "A software issue could potentially cause the stand and table movements to be blocked". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1496-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-14
Posted: 2020-03-13
Terminated: 2021-04-20
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: A software issue could potentially cause the stand and table movements to be blocked.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 1452 worldwide (638 US)
Distribution: US Nationwide distribuiton.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1496-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13
Z-1497-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)