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Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113,...

FDA Recall #Z-1492-2014 — Class II — December 4, 2013

Recall #Z-1492-2014 Date: December 4, 2013 Classification: Class II Status: Terminated

Product Description

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

Reason for Recall

Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

Recalling Firm

Ion Beam Applications S.A. — Louvain La Neuve, N/A

Classification

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

Product Type

Devices

Product Quantity

4

Distribution

US Distribution including the states of OK, IL, NJ, and WA.

Code Information

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.

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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