CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

Philips Fetal Spiral Electrode-intended recalled

Philips North America is recalling Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate, distributed nationwide in the US. The recall was initiated on 21 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022

Quantity recalled69,679 cases (1,741,975 units)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0908-2023
FDA event ID: 91220
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2022
FDA classified: 6 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

21 Nov 2022	Recall initiated by company
6 Jan 2023	Classified by FDA	+46 days
18 Jan 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate recalled?

Yes. Philips North America recalled Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate on 21 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0908-2023.

Why was it recalled?

Which lots are affected?

UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Philips North America

All 531

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
26 Aug 2026Device	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Labeling Errors	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide