FDA Enforcement
Class II
Terminated
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray System
Recall: Z-0680-2017
·
Reported December 14, 2016
Enforcement
- Recall Number
- Z-0680-2017
- Event ID
- 75575
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Scientific Solutions Americas
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- December 14, 2016
- Initiation Date
- October 27, 2016
- Classification Date
- December 7, 2016
- Termination Date
- July 30, 2020
- Address
- 48 Woerd Ave, N/A, Waltham, MA, 02453-3824, United States
Description
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.
Code Info
Model - Vanta VCR
Distribution
US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
Quantity
41 units