FDAClass IIJuly 31, 2013

Axiom Aristos MX Solid State Flat Panel Digital Imager recall

Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

Why was Axiom Aristos MX Solid State Flat Panel Digital Imager recalled?

Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee

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 Number 5895003 with serial numbers 1052 through 2500.

Product
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
401
Distribution
Nationwide Distribution.
Recall date
July 31, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls