Z-1342-2022Class II

Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

Name: Z-1342-2022 Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-05-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-05-20 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 on 2022-05-20. FDA classified it as Class II and gives the reason as "During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1342-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-20
Posted: 2022-07-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On May 20, 2022, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were informed that in the event this issue occurs, the system will switch to Bypass fluoroscopy mode. In Bypass fluoroscopy mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Customer Instructions: In the event you recognize a high squeaking scratching loud noise out of one of the system cabinets, please contact your service partner for immediate action. It is recommended to avoid performing any critical interventions on the system. Due to the possible risk of electrical shock to the technician, please ensure that your service partner (if not Siemens Healthineers) first contacts Siemens Healthineers' service organization before starting any corrective actions. The firm will replace the affected parts. The service organization will contact customers to arrange a date to perform the corrective action. To schedule an earlier appointment, contact the firm at 1-800-888-7436.
Quantity in commerce: 195 worldwide, 88 US
Distribution: Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam.
Product codes and lots: UDI-DI: 04056869063317 Serial Numbers: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180349 180367 180382 180060 180399 180337 180070 180048 180083 180369 180370 180371 180372 180345 180315 180343 180080 180301 180305 180067 180330 180040 180379 180386 180360 180333 180029 180352 180336 180407 180400 180397 180316 180068 180363 180084 180334 180018 180350 180376 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180381 180021 180342 180321 180309 180356 180378 180393 180368 180341 180323 180329 180043 180049 180377 180077 180086 180053 180055 180015 180014 180066 180082 180037 180373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1342-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1342-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-06

Product code JAK

K193326Class IIARTIS IconoSiemens Medical Solutions USA, Inc. / cleared 2020-04-16

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)