Mammomat Revelation with software version VC10 and recall
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy…
Why was Mammomat Revelation with software version VC10 and 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
software version VC10 and Biopsy Option
- Product
- Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 139 WW (33 US)
- Distribution
- Nationwide
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)