Recall Z-0711-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-09-28, terminated 2020-03-09. It names 3 FDA 510(k) clearances: K052202, K021021, K010721. Product: Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.. Reason: The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-28
- Terminated
- 2020-03-09
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K052202 — AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
- K021021 — MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
- K010721 — AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
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
Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Reason for recall
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
Data sourced from openFDA. This site is unofficial and independent of the FDA.