Class 2 Device Recall MAMMOMAT Revelation

• Date Initiated by Firm: May 07, 2020
• Date Posted: June 16, 2020
• Recall Status: Terminated on September 29, 2022
• Recall Number: Z-2388-2020
• Recall Event ID: 85719
• 510(K)Number: K173408
• Product Classification: Full field digital, system, x-ray, mammographic - Product Code MUE
• Product: MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
• Code Information: Serial Numbers (distributed in the US): 1026 1057 1348 1426 1027 1274 1292 1360 1324 1728 1372 1744 1036 1038 1620 1235 1751 1423 1379 1425 1342 1740 1445 1650 1058 1409 1277 1025 1253 1225 1749 1747 1422 1275 1228 1449 1707 1767 1387 1391 1206 1217 1250 1082 1357 1354 1256 1031 1339 1034 1219 1437 1289 1359 1045 1429 1408 1717 1051 ***Updated 8/18/2020*** 1775 1784 1785 1795 1797
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355
• For Additional Information Contact: Service organization; 800-888-7436
• Manufacturer Reason for Recall: If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
• FDA Determined Cause: Device Design
• Action: On May 7, 2020, the firm distributed Urgent Medical Device Correction letters to all affected customers. Customers were informed of the potential issue on their MAMMOMAT Revelation system with software versions VC10B, VC10C, or VC10D with Tomo Biopsy Unit option and the InSpect functionality, and the relevant corrective action that would be performed on these systems to prevent possible hazard to patients. The firm stated they do not consider it necessary to re-examine any patients in this case as the error had no influence on the previous treatment of patients. If the operator experiences difficulty removing the vacuum biopsy system due to the device error, they should take the following actions to avoid potential risks: - The InSpect PV functionality should be deactivated by using a right mouse click, selecting PV option and choosing deactivate function. - Following this action, the normal biopsy mode remains active, and the tube head can be moved to the ¿15 degrees position, providing enough space to easily remove the vacuum needle out of the needle holder. Siemens Healthineers will provide a field software update VC10E for MAMMOMAT Revelation with VC10B, VC10C, and VC10D versions that will eliminate the issue described. This correction will be provided free of charge and is planned to be available in the third quarter of 2020. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact firm's service organization for an earlier appointment at 1-800-888-7436. Customers were asked confirm acknowledgement of the information and instructions contained in the letter. If product was further distributed, please identify your customers and notify them of this recall.
• Quantity in Commerce: 230 worldwide (64 US)
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MUE and Original Applicant = Siemens Medical Solutions, Inc.