Z-0160-2020Class II

Mammomat Revelation with software version VC10 and Biopsy Option

Name: Z-0160-2020 Mammomat Revelation with software version VC10 and Biopsy Option
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy... on 2019-07-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0160-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-23
Posted: 2019-10-18
Terminated: 2020-05-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
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
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued the customer notification on 7/23/19 via XP018/19/S. The Advisory Notice provides the problem, health risk and action to take: provided steps to the operator on how to easily release patient and proceed with exam. Siemens is developing a corrective action to resolve the issue, which will be released via Update Instruction XP021/19/S.
Quantity in commerce: 139 WW (33 US)
Distribution: Nationwide
Product codes and lots: software version VC10 and Biopsy Option

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0160-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0160-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-18

Product code MUE

K173408Class IIMammomat RevelationSiemens Medi Cal Solutions, Inc. / cleared 2018-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)