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steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images ...

FDA Recall #Z-0580-2014 — Class II — November 29, 2013

Recall #Z-0580-2014 Date: November 29, 2013 Classification: Class II Status: Terminated

Product Description

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 system for acceptance , transfer, display and digital processing of two 3D x-ray images.

Reason for Recall

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

Recalling Firm

EOS Imaging — Paris France, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

36 units

Distribution

USA Nationwide Distribution

Code Information

Software versions: 1.3, 1.4 and 1.5

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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