FDA Enforcement
Class II
Terminated
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Recall: Z-0803-2016
·
Reported March 2, 2016
Enforcement
- Recall Number
- Z-0803-2016
- Event ID
- 73251
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Olympus Scientific Solutions Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 2, 2016
- Initiation Date
- January 13, 2016
- Classification Date
- February 19, 2016
- Termination Date
- May 18, 2021
- Address
- 48 Woerd Ave, N/A, Waltham, MA, 02453-3824, United States
Description
Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system
Reason
The Firm has discovered a Software bug.
Code Info
All models of the Delta XRF Analyzer
Distribution
Worldwide Distribution - USA (nationwide) Distribution
Quantity
US - 5000 units