Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and

FDA device recall Z-2127-2020 · posted 2020-05-04 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

OWB

Quantity affected

58

Distribution

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.

Date initiated

2020-04-17

Date posted

2020-05-04

Date terminated

2020-08-25

Location

Malvern, PA

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