FDAClass IIApril 6, 2016

Cios Alpha recall: Software Issue

Cios Alpha, mobile X-ray system

Why was Cios Alpha recalled?

Software issues on Cios Alpha mobile C-Arm system

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?

Model # 10308191

Product
Cios Alpha, mobile X-ray system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
89 systems
Distribution
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI
Recall date
April 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls