FDAClass IINovember 4, 2015

Cios Alpha recall

CIOS ALPHA; image intensified fluoroscopic x-ray system

Why was Cios Alpha recalled?

patient procedure interruption due to a potential system failure

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 with serial numbers: Serial 11032 10073 11132 11044 11005 10115 11056 10057 10076 10019 10035 11074 11075 11077 11083 11124 10078 11119 11103 11105 11013 10021 10037 10063 11106 10082 11098 11094 10089 11080 11009 11018 11082 10058 10098 11120 11134 11015 11016 11038 10116 11035 11107 11064

Product
CIOS ALPHA; image intensified fluoroscopic x-ray system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
44
Distribution
Nationwide Distribution.
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls