Z-0170-2016 Class II Terminated
FDA device recall Z-0170-2016 was initiated by Varian Medical Systems, Inc. on September 28, 2015 and is designated Class II. Reason for recall: An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx. The recall status is terminated (terminated May 12, 2017). Affected quantity: 1971 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2015
- Initiation Date
- September 28, 2015
- Termination Date
- May 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1971 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.