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Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT201...

FDA Recall #Z-0948-2013 — Class II — November 27, 2012

Recall #Z-0948-2013 Date: November 27, 2012 Classification: Class II Status: Terminated

Product Description

Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.

Reason for Recall

Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

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

Product Type

Devices

Product Quantity

896

Distribution

Nationwide Distribution.

Code Information

Model numbers - 7740769, 8098027, 10430603, and 10590000.

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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