FDAClass IIMay 20, 2020

Siemens Cios Spin VA30-mobile X-Ray system recall

Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to…

Why was Siemens Cios Spin VA30-mobile X-Ray system recalled?

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers: 50124 50135 50131 50171 50129 50032 50033 50048 50050 50051 50073 50075 50081 50088 50098 50107 50109 50111 50120 50196 50102 50180 50136 50185 50096 50155 50091 50130 50127 50077 50078 50134 50122 50101 50092 50094 50166 50049 50192 50161 50125 50128 50132 50079 50160 50030

Product
Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
46 units
Distribution
US Nationwide distributions.
Recall date
May 20, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls