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 Fetal Spiral Electrode

  • 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 Fetal Spiral Electrode see related information
Date Initiated by Firm January 25, 2019
Create Date May 02, 2019
Recall Status1 Terminated 3 on December 08, 2020
Recall Number Z-1250-2019
Recall Event ID 82422
510(K)Number K030691  
Product Classification Electrode, circular (spiral), scalp and applicator - Product Code HGP
Product Fetal Spiral Electrode, Model No. 9898 031 37631
Code Information All products currently in distribution.
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
FDA Determined
Cause 2		 Under Investigation by firm
Action On January 25, 2019, the firm distributed Customer Information Medical Device Correction letters to affected customers. The letter informed customers that there was an increase in complaints regarding the Fetal Spiral Electrode tip breaking off, preventing easy removal from the scalp of the newborn infant. Customers were advised to do the following: * Visually examine the FSE upon removal from the newborn scalp to verify the tip is intact. If it is not intact, appropriate measures to locate and remove the missing part should be taken. * Upon receipt of this notice, clinicians should review the following information from the device's Instructions for Use: - Do not pull the Spiral Tip from the fetal skin. Do not pull the FSE wires apart. - Do not over-rotate Spiral Tip during attachment. - Inspect the Spiral Tip to ensure that it is still attached to the FSE Hub. If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique. Customers were provided with a reply form and asked to complete the form and return it to Philips: 1-877-499-7223 (eFax) or email to recall.response@philips.com. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377, option 2.
Quantity in Commerce 1,971,925 (78,877 boxes)
Distribution Distributed nationwide within US. Worldwide international distribution.
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 = HGP and Original Applicant = CLINICAL INNOVATIONS, INC.
-
-