Recall Z-2435-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-2435-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-31

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2015-07-31, terminated 2016-12-23. It names one FDA 510(k) clearance: K142006. Product: Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.. Reason: Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Terminated: 2016-12-23
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142006 — SYMBIA 6.0Siemens Medical Solutions USA, Inc.·cleared 2014-08-21

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 Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.

Reason for recall

Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbia lntevo systems. These fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly.

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