FDA Enforcement
Class II
Terminated
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Recall: Z-1036-2017
·
Reported February 8, 2017
Enforcement
- Recall Number
- Z-1036-2017
- Event ID
- 76208
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Scientific Solutions Americas
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- February 8, 2017
- Initiation Date
- January 7, 2017
- Classification Date
- February 1, 2017
- Termination Date
- August 27, 2019
- Address
- 48 Woerd Ave, N/A, Waltham, MA, 02453-3824, United States
Description
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Reason
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.
Code Info
affects all units.
Distribution
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.
Quantity
US 74