Z-1934-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- October 15, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Reason for Recall
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Distribution Pattern
US: NJ, MI, SC, NC, MI, AR, OUS: None
Code Information
Product Version: 4.4.128