Recall Z-1036-2017— Olympus Scientific Solutions Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Scientific Solutions Americas, initiated 2017-01-07, terminated 2019-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Olympus Scientific Solutions Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-07
- Terminated
- 2019-08-27
- Firm location
- Waltham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.