Z-1036-2017 Class II Terminated
FDA device recall Z-1036-2017 was initiated by Olympus Scientific Solutions Americas on January 7, 2017 and is designated Class II. Reason for recall: It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate… The recall status is terminated (terminated August 27, 2019). Affected quantity: US 74.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- January 7, 2017
- Termination Date
- August 27, 2019
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US 74
Product Description
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Reason for Recall
It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.
Distribution Pattern
US Distribution to the states of : PA, MA, CO, OH, NJ, GA, CA, TX, IL, VA, MN, NH, WA, SC, AZ, LA, MD, OK, IN, NY, NC and KS.
Code Information
affects all units.