Philips North America Llc: Medical Device Recall in 2023 - (Recall #: Z-0908-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 21, 2022

Date Posted: January 18, 2023

Recall Number: Z-0908-2023

Event ID: 91220

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.

Status: Ongoing

Product Quantity: 69,679 cases (1,741,975 units)

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated