Recall Z-2127-2020— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-04-17, terminated 2020-08-25. It names one FDA 510(k) clearance: K181560. Product: Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.. Reason: The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-17
- Terminated
- 2020-08-25
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Reason for recall
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.