—#143817

Product

Mammomat Inspiration with Tomosynthesis functionality

FDA product code: OTE — Digital Breast Tomosynthesis
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P140011
Affected lot / code info: Model number: 10140000

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-02-12
Terminated: 2017-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.