• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Magnetom Espree System with OR Table

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Magnetom Espree System with OR Table
see related information
Date Posted April 26, 2007
Recall Status1 Terminated on August 07, 2007
Recall Number Z-0769-2007
Recall Event ID 37760
Premarket Notification
510(K) Number
K041112 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Magnetom Espree System with OR Table
Code Information Model number 10092082, serial number 1002, 1003, and 1004.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Roland Richter
610-448-1777
Manufacturer Reason
for Recall
If table top is not seated properly it can lock up/stick.
FDA Determined
Cause 2
DESIGN: Device Design
Action The recalling firm issued a Safety Advisory Letter to their customers on March 30, 2007, informing them of the problem and steps to take to avoid the problem.
Quantity in Commerce 3 units
Distribution The product was shipped to medical facilities in NY and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
-
-