Class 2 Device Recall Philips

• Date Initiated by Firm: November 21, 2022
• Date Posted: January 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0908-2023
• Recall Event ID: 91220
• 510(K)Number: K030691
• Product Classification: Electrode, circular (spiral), scalp and applicator - Product Code HGP
• Product: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor.; PN: 989803137631
• Code Information: UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HGP and Original Applicant = CLINICAL INNOVATIONS, INC.