Recall Z-0469-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0469-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-21

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-10-21, terminated 2021-05-05. It names one FDA 510(k) clearance: K181407. Product: 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: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-10-21
Terminated: 2021-05-05
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181407 — Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.·cleared 2018-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.