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 Edwards' MHANM8 Pressure Slave Cable

  • 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 Edwards' MHANM8 Pressure Slave Cable see related information
Date Initiated by Firm June 25, 2010
Date Posted October 28, 2010
Recall Status1 Terminated 3 on May 24, 2011
Recall Number Z-0160-2011
Recall Event ID 56148
510(K)Number K060660  
Product Classification Computer, diagnostic pre-programmed, single-function - Product Code DXG
Product Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001
The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
Code Information Lot Numbers: 58822824; 58821774
Recalling Firm/
Manufacturer		 Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact
949-250-2500
Manufacturer Reason
for Recall		 The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
FDA Determined
Cause 2		 Process design
Action Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.
Quantity in Commerce 20 units
Distribution Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
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 = DXG and Original Applicant = EDWARDS LIFESCIENCES, LLC.
-
-