Z-0160-2020 Class II Terminated
FDA device recall Z-0160-2020 was initiated by Siemens Medical Solutions USA, Inc on July 23, 2019 and is designated Class II. Reason for recall: An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases The recall status is terminated (terminated May 6, 2020). Affected quantity: 139 WW (33 US).
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- July 23, 2019
- Termination Date
- May 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 139 WW (33 US)
Product Description
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Reason for Recall
An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare cases
Distribution Pattern
Nationwide
Code Information
software version VC10 and Biopsy Option