Recall Z-0680-2017— Olympus Scientific Solutions Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Scientific Solutions Americas, initiated 2016-10-27, terminated 2020-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System. Reason: Possible unintentional x-ray emission after users attempt early termination of the sequence..
- Recalling firm
- Olympus Scientific Solutions Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-27
- Terminated
- 2020-07-30
- Firm location
- Waltham, MA, United States
Product description
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System
Reason for recall
Possible unintentional x-ray emission after users attempt early termination of the sequence.
Data sourced from openFDA. This site is unofficial and independent of the FDA.