Recall Z-0116-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-0116-2015
Creator: U.S. Food and Drug Administration
Published: 2013-10-28

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2013-10-28, terminated 2016-12-23. It names one FDA 510(k) clearance: K952109. Product: e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.. Reason: Reports of loose bolts in the detector support structure of Symbia and e.cam systems..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Terminated: 2016-12-23
Firm location: Hoffman Estates, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K952109 — IP500 NUCLEAR GAMMA CAMERA SYSTEMSiemens Medical Solutions USA, Inc.·cleared 1995-08-23

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

e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

Reason for recall

Reports of loose bolts in the detector support structure of Symbia and e.cam systems.

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