FDAClass IINovember 20, 2013

Artis zee systems x-ray recall

Artis zee systems x-ray, angiographic system

Why was Artis zee systems x-ray recalled?

The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.

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 numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot

Product
Artis zee systems x-ray, angiographic system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
17
Distribution
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
Recall date
November 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls