Z-0888-2016Class II

Mammomat Inspiration with Tomosynthesis functionality

Name: Z-0888-2016 Mammomat Inspiration with Tomosynthesis functionality
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-12
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-12 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mammomat Inspiration with Tomosynthesis functionality on 2016-02-12. FDA classified it as Class II and gives the reason as "A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for...". 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-0888-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-02-25
Terminated: 2017-11-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mammomat Inspiration with Tomosynthesis functionality
Product code: OTE Digital Breast Tomosynthesis
Reason for recall: A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The syste
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Field Safety Notice dated February 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. How will the issue finally be resolved? Siemens is releasing a field modification to resolve this issue as soon as possible. The upgrade software (VB30P) will be available to the affected customers free of charge. A Siemens service engineer will contact you to schedule implementation of the modification for your system. According to regulations set forth in 21 CFR 7.49(d), we advise that you follow the instructions in this notice and where necessary request that you promptly notify and instruct all the staff at your organization who have to be aware of this problem. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. We thank you for your cooperation. For further questions, please call (610) 448-6478.
Quantity in commerce: 76 units
Distribution: Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.
Product codes and lots: Model number: 10140000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0888-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0888-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code OTE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)