Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Reported: July 13, 2022 Initiated: May 20, 2022 #Z-1342-2022
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.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 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.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 195 worldwide, 88 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1342-2022.
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