FDAClass IIJanuary 1, 2014

steroEOS Workstation with software versions: 1.3 recall

steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general…

Why was steroEOS Workstation with software versions: 1.3 recalled?

Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation

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?

Software versions: 1.3, 1.4 and 1.5

Product
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general…
Recalling firm
EOS Imaging
Quantity
36 units
Distribution
USA Nationwide Distribution
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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