Date Initiated by Firm |
June 30, 2009 |
Date Posted |
September 21, 2009 |
Recall Status1 |
Terminated 3 on October 01, 2010 |
Recall Number |
Z-2232-2009 |
Recall Event ID |
52959 |
510(K)Number |
K060065
|
Product Classification |
ventilator monitor - Product Code CCK
|
Product |
Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659. |
Code Information |
Software version V 3.0 and earlier. Part Number Part Description CS08651, Capnostream20 with Nellcor pulse oximetry module CS08653 Capnostream20 with Masimo pulse oximetry module CS08657 Capnostream20 with Nellcor pulse oximetry module and printer CS08659 Capnostream20 with Masimo pulse oximetry module and printer |
Recalling Firm/ Manufacturer |
Oridion Medical 1987 Ltd. 7 Hamarpe St., P.O. Box 45025 Har Hotzvim Industrial Park Jerusalem Israel
|
For Additional Information Contact |
888-674-3466
|
Manufacturer Reason for Recall |
1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze.
2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices
|
FDA Determined Cause 2 |
Device Design |
Action |
Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full. |
Quantity in Commerce |
326 units |
Distribution |
Nationwide. |
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 = CCK and Original Applicant = ORIDION CAPNOGRAPHY, INC.
|