Recall Z-0480-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0480-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-10

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-10-10, terminated 2014-01-15. It names one FDA 510(k) clearance: K111912. Product: Siemens Mobilette Mira, intended use as Mobile x-ray system.. Reason: There is a risk of lost images during examination..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Terminated: 2014-01-15
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K111912 — MOBILETT MIRASiemens Medical Solutions USA, Inc.·cleared 2011-09-19

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

Siemens Mobilette Mira, intended use as Mobile x-ray system.

Reason for recall

There is a risk of lost images during examination.

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