—#181257

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181560
Affected lot / code info: Serial Numbers: 11200 13288 13259 12339 13241 10019 12377 13219 12946 13232 13045 12618 12972 40109 40110 40073 40057 40013 40082 40093 40078 40107 40108 40111 40120 40126 40134 40135 40104 40074 40095 40076 40080 40058 40077 40081 40055 40054 40075 40125 40113 40102 40071 40061 40094 40124 40070 40103 40118 40119 40121 40084 40122 40123 40083 40062 40130 40116

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

URGENT: MEDICAL DEVICE CORRECTION notification letters dated 4/17/20 were sent to customers. What is the impact to the operation of the system and what are the possible risks? There is no impact to the operation of the system, however, unplugging the main cable can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector which can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. How was the subject identified and what is the root cause? The issue was identified by the manufacturer during system assembly when the plug of the main cable was unplugged. The root cause is a design flaw in a generator component of the generator Polydoros M25 revision 04. What actions do we recommend urgently to mitigate possible risks? We strongly recommend that you do not unplug the main cable until the generator is repaired by a service engineer. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the hardware error via Update Instruction AX028/20/S in which a Siemens Service Engineer will repair the generator at your site. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.

Timeline

Recall initiated: 2020-04-17
Posted by FDA: 2020-05-04
Terminated: 2020-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.