Recall Z-1638-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1638-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-25

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-04-25, terminated 2014-12-15. It names one FDA 510(k) clearance: K122286. Product: MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.. Reason: There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Terminated: 2014-12-15
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K122286 — MAMMOMAL INSPIRATIONSiemens Medical Solutions USA, Inc.·cleared 2013-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

Reason for recall

There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.