Z-0908-2023Class II

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN...

Name: Z-0908-2023 Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN...
Creator: Philips North America Llc
Published: 2022-11-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2022-11-21 / Open, Classified

FDA source

Philips North America Llc began a recall of Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 on 2022-11-21. FDA classified it as Class II and gives the reason as "Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0908-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-21
Posted: 2023-01-06
Recalling firm: Philips North America LLC
Product: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Product code: HGP Electrode, Circular (Spiral), Scalp And Applicator
Reason for recall: Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
FDA root cause: Under Investigation by firm
Action: Philips Medical issued to U.S. customers, the Urgent Medical Device Correction (UMDC) letter via certified mail 11/21/22. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take. Philips has decided to discontinue the distribution of this product. To limit the potential for the spiral tip of the FSE to break off in the patient s scalp, it is important to avoid over rotation during attachment or pulling the tip from the fetal scalp Customer should complete the Urgent Field Safety Notice Response Form online to submit both their acknowledgement of this recall (mandatory) and actions taken, as well as request for credit (optional). To request credit go to URL: https://forms.office.com/r/GsLVh2gYZi Pass this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (If appropriate). If you choose, discard all FSEs sold by Philips and source from an alternative supplier available in your country. If you choose to discard the FSEs, we will issue a credit after you complete the online response form. Actions planned by Philips Hospital Patient Monitoring to correct the problem " Philips is continuing to investigate additional root causes with FSE supplier " Philips will immediately discontinue selling the FSEs " Philips will reimburse for any discarded FSEs
Quantity in commerce: 69,679 cases (1,741,975 units)
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Croatia, Cura¿ao, Czechia, Denmark, Faroe Islands, Finland, France, Germany, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tanzania, United Republic Trinidad and Tabago, United Arab Emerates, United Kingdom.
Product codes and lots: UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0908-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0908-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

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)