Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall M19 (Iridium 192)

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


New Search Back to Search Results
  Class 2 Device Recall M19 (Iridium 192) see related information
Date Initiated by Firm March 03, 2008
Create Date June 25, 2015
Recall Status1 Terminated 3 on August 19, 2009
Recall Number Z-1717-2009
Recall Event ID 52428
510(K)Number K052947  
Product Classification Source, brachytherapy, radionuclide - Product Code KXK
Product M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA.

Brachytherapy source.
Code Information OSI A011, OSI A010, and OSI A015.
Recalling Firm/
Manufacturer		 Source Production & Equipment Inc
113 Teal St
St Rose LA 70087-4022
For Additional Information Contact Kevin Schehr
504-464-9471
Manufacturer Reason
for Recall		 Radioactive source broke during use.
FDA Determined
Cause 2		 Other
Action Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.
Quantity in Commerce 3 units
Distribution Nationwide Distribution -- GA, NV and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KXK and Original Applicant = SOURCE PRODUCTION & EQUIPMENT CO., INC.
-
-