Z-1339-2019Class II

Artis Zee (material # 10094135, 10094137, 10094141) -

Name: Z-1339-2019 Artis Zee (material # 10094135, 10094137, 10094141) -
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-04-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-04-09 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for... on 2019-04-09. FDA classified it as Class II and gives the reason as "In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement". 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-1339-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-09
Posted: 2019-05-15
Terminated: 2020-04-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: IZI System, X-Ray, Angiographic
Reason for recall: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Root cause tag: software
FDA root cause: Software design
Action: On April 9, 2019, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that ARTIS systems equipped with certain motor control units may encounter with hardware failure, and planned procedures may need to be terminated and performed on an alternative x-ray system. The firm stated their service organization would contact customers shortly to arrange a date to perform a software update to correct the issue. For an earlier appointment or if you have any questions, you may contact the firm at 1-800-888-7436. Customers were asked to promptly notify and instruct all staff at the organization who need to be aware of the notice. Additionally, if you further distributed the product, please identify your customers and notify them at once of this recall.
Quantity in commerce: 459 (116 US)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries.
Product codes and lots: Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1339-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1339-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1340-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1341-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15
Z-1342-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-15

Product code IZI

K073290Class IIArtis Zee and ZeegoSiemens Medical Solutions USA, Inc. / cleared 2008-02-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)