Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Reported: October 30, 2019 Initiated: July 23, 2019 #Z-0160-2020
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 139 WW (33 US)
- Distribution
- Nationwide
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 139 WW (33 US).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2019. Severity: Moderate. Recall number: Z-0160-2020.
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