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 Fabius GS Anesthesia Machine

  • 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 Fabius GS Anesthesia Machine see related information
Date Initiated by Firm October 03, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 on August 07, 2007
Recall Number Z-0048-2007
Recall Event ID 36476
510(K)Number K042419  
Product Classification Anesthesia Machine - Product Code BSZ
Product Fabius GS Anesthesia Machine. Catalog number 8604699
Code Information Catalog number 8604699
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall		 One of four casters may break loose from chassis
FDA Determined
Cause 2		 Other
Action The recalling firm issued recall letters to their customers 10/03/2006 to inform them of the problem and that a service represenative will contact them to schedule an inspection of their machines. Should the inspections revealed any affected machines, the machines will be repaired free of charge.
Quantity in Commerce 429 units
Distribution Nationwide and Canada.
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 = BSZ and Original Applicant = DRAEGER MEDICAL, INC.
-
-