Z-1250-2019Class II

Fetal Spiral Electrode, Model No. 9898 031 37631

Name: Z-1250-2019 Fetal Spiral Electrode, Model No. 9898 031 37631
Creator: Philips North America, LLC
Published: 2019-01-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2019-01-25 / Terminated

FDA source

Philips North America, LLC began a recall of Fetal Spiral Electrode, Model No. 9898 031 37631 on 2019-01-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1250-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-25
Posted: 2019-05-02
Terminated: 2020-12-08
Recalling firm: Philips North America LLC
Product: Fetal Spiral Electrode, Model No. 9898 031 37631
Product code: HGP Electrode, Circular (Spiral), Scalp And Applicator
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 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 [email protected]. 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.
Product codes and lots: All products currently in distribution.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1250-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1250-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-08	2019-05-02

Product code HGP

K030691Class IIFetal Spiral Electrode, Model Fse07000Clinical Innovations, Inc. / cleared 2003-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)