FDA Medical Device Recalls (openFDA)
Philips North America, LLC: Fetal Spiral Electrode, Model No. 9898 031 37631
- Recall number
- Z-1250-2019
- Recalling firm
- Philips North America, LLC
- Product
- Fetal Spiral Electrode, Model No. 9898 031 37631
- Status
- Terminated
- Initiated
- 2019-01-25
- Posted
- not on file
- Terminated
- 2020-12-08
- Reason
- 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.
- Root cause
- 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
- 1,971,925 (78,877 boxes)
- Distribution
- Distributed nationwide within US. Worldwide international distribution.
- Lot, serial or model codes
- All products currently in distribution.
- 510(k) numbers
- ["K030691"]
- PMA numbers
- not on file
- Product code
- HGP
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28