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Class 2 Device Recall Fetal Spiral Electrode |
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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
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Product Classification |
Electrode, circular (spiral), scalp and applicator - Product Code HGP
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Product |
Fetal Spiral Electrode, Model No. 9898 031 37631
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Code Information |
All products currently in distribution. |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact |
Philips Customer Services 800-722-9377
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HGP and Original Applicant = CLINICAL INNOVATIONS, INC.
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