Recall Z-1250-2019— Philips North America, LLC

Name: FDA recall Z-1250-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-25

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2019-01-25, terminated 2020-12-08. It names one FDA 510(k) clearance: K030691. Product: Fetal Spiral Electrode, Model No. 9898 031 37631. Reason: During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-01-25
Terminated: 2020-12-08
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000Clinical Innovations, Inc.·cleared 2003-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fetal Spiral Electrode, Model No. 9898 031 37631

Reason for recall

During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.