Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 9898031376
Summary
The FDA issued a Class II for Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate by Philips North America Llc. Reason: Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neona.
Details
Source
Device Recall
External ID
Z-0908-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
Product Description
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631
Lot/Code Info: UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022
Quantity Affected: 69,679 cases (1,741,975 units)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-21
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0908-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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