FDA recall Z-2388-2020

Siemens Medical Solutions USA, Inc · Class II · device

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.

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.

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-05-07
Report date
2020-06-24
Termination date
2022-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2388-2020