Z-0680-2017 Class II Terminated
FDA device recall Z-0680-2017 was initiated by Olympus Scientific Solutions Americas on October 27, 2016 and is designated Class II. Reason for recall: Possible unintentional x-ray emission after users attempt early termination of the sequence. The recall status is terminated (terminated July 30, 2020). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2016
- Initiation Date
- October 27, 2016
- Termination Date
- July 30, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 41 units
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.
Distribution Pattern
US Distribution to the states of : TX, WA, GA, MA, SC, AZ, PA, VA, CA, OH, NJ, MD, CO, IL, LA, and MN.
Code Information
Model - Vanta VCR