Z-0005-2019 Class II Terminated
FDA device recall Z-0005-2019 was initiated by Varian Medical Systems on August 20, 2018 and is designated Class II. Reason for recall: Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on mo… The recall status is terminated (terminated August 28, 2020). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- August 20, 2018
- Termination Date
- August 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of : Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom