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

Class 2 Device Recall Magnetom Sonata syngo

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


New Search Back to Search Results
 Class 2 Recall
Magnetom Sonata syngo
see related information
Date Posted March 25, 2008
Recall Status1 Open
Recall Number Z-1046-2008
Recall Event ID 46245
Premarket Notification
510(K) Number
K970852 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355
Code Information Serial Number: 21936
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355-1406
For Additional Information Contact Catherine Moffa
610-448-4500
Manufacturer Reason
for Recall
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution
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.
-
-