CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Mammomat Revelation recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Mammomat Revelation, distributed nationwide in the US. The recall was initiated on 23 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codessoftware version VC10 and Biopsy Option

Quantity recalled139 WW (33 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0160-2020
FDA event ID: 83508
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jul 2019
FDA classified: 18 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

23 Jul 2019	Recall initiated by company
18 Oct 2019	Classified by FDA	+87 days
30 Oct 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures

Where it was distributed

Nationwide

Questions about this recall

Why was it 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 lots are affected?

software version VC10 and Biopsy Option

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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