Z-0469-2021 Class II Terminated
FDA device recall Z-0469-2021 was initiated by Siemens Medical Solutions USA, Inc on October 21, 2020 and is designated Class II. Reason for recall: Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properl… The recall status is terminated (terminated May 5, 2021). Affected quantity: 26 distributed worldwide (4 in US).
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 21, 2020
- Termination Date
- May 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 distributed worldwide (4 in US)
Product Description
Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - 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.
Reason for Recall
Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.
Code Information
Serial numbers 109762 111158 124344 111161