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Z-0050-2018 Class II Terminated

Recalled by Nucletron BV — Veenendaal, N/A

FDA device recall Z-0050-2018 was initiated by Nucletron BV on August 10, 2017 and is designated Class II. Reason for recall: Incorrect source step size may occur in the software plans The recall status is terminated (terminated November 20, 2020). Affected quantity: 89 customer sites have the affected software.

Recall Details

Product Type: Devices
Report Date: November 1, 2017
Initiation Date: August 10, 2017
Termination Date: November 20, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89 customer sites have the affected software

Product Description

Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

Reason for Recall

Incorrect source step size may occur in the software plans

Distribution Pattern

Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.

Code Information

Versions 4.5, 4.5.1, and 4.5.2.