MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagno

FDA device recall Z-2388-2020 · posted 2020-06-16 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

MUE

Quantity affected

230 worldwide (64 US)

Distribution

US Nationwide distribution.

Date initiated

2020-05-07

Date posted

2020-06-16

Date terminated

2022-09-29

Location

Malvern, PA

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