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 Reusable Ohmeda Compatible Finger Clip Sensor

  • 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 Reusable Ohmeda Compatible Finger Clip Sensor see related information
Date Initiated by Firm May 18, 2007
Date Posted June 26, 2008
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-1188-2008
Recall Event ID 46397
510(K)Number K970098  
Product Classification Oxygen Monitor - Product Code DQA
Product Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614
Code Information Serial Numbers: YE508/001, YE508/002, YE508/003, YE508/004, YE508/005, YE508/006, YE508/007, YE508/008, YE508/009, YE508/010; ZC502/001, ZC502/002, ZC502/003, ZC502/004, ZC502/005, ZC502/006; ZG512/001, ZG512/002, ZG512/003, ZG512/004, ZG512/005, ZG512/006, ZG512/007, ZG512/008, ZG512/009, ZG512/010, ZG512/011, ZG512/012, ZG512/013, ZG512/014, ZG512/015; PA514/001, PA514/002, PA514/003, PA514/004, PA514/005, PA514/006, PA514/006, PA514/007, PA514/008, PA514/009, PA514/010; PA515/001, PA515/002, PA515/003, PA515/004, PA515/005, PA515/006, PA515/007, PA515/008, PA515/009, PA515/010, PA515/011, PA515/012, PA515/013, PA515/014, PA515/015, PA515/016, PA515/017, PA515/018, PA515/019, PA515/020, PA515/021, PA515/022, PA515/023, PA515/024, PA515/025, PA515/026, PA515/027, PA515/028, PA515/029, PA515/030, PA515/031, PA515/032, PA515/033, PA515/034 and PA515/035
Recalling Firm/
Manufacturer		 Kentec Medical Inc
17871 Fitch
Irvine CA 92614-6001
For Additional Information Contact Keith Rooks
800-825-5996
Manufacturer Reason
for Recall		 Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.
FDA Determined
Cause 2		 Process change control
Action Consignees were notified via telephone on 5/18/07 and an "Important Voluntary Market Withdrawal Notice" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996.
Quantity in Commerce 41
Distribution Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.
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 = DQA and Original Applicant = EPIC MEDICAL EQUIPMENT SERVICES, INC.
-
-