—#197270

Product

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

FDA product code: HGP — Electrode, Circular (Spiral), Scalp And Applicator
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K030691
Affected lot / code info: UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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.

Timeline

Recall initiated: 2022-11-21
Posted by FDA: 2023-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197270. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.