Home / Recalls / Siemens Medical Solutions USA, Inc / Z-1342-2022

Z-1342-2022 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1342-2022 was initiated by Siemens Medical Solutions USA, Inc on May 20, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 195 worldwide, 88 US.

Recall Details

Product Type: Devices
Report Date: Jul 13, 2022
Initiation Date: May 20, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 195 worldwide, 88 US

Product Description

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

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.

Distribution Pattern

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1342-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.