—#171593

Product

Fetal Spiral Electrode, Model No. 9898 031 37631

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: All products currently in distribution.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 25, 2019, the firm distributed Customer Information Medical Device Correction letters to affected customers. The letter informed customers that there was an increase in complaints regarding the Fetal Spiral Electrode tip breaking off, preventing easy removal from the scalp of the newborn infant. Customers were advised to do the following: * Visually examine the FSE upon removal from the newborn scalp to verify the tip is intact. If it is not intact, appropriate measures to locate and remove the missing part should be taken. * Upon receipt of this notice, clinicians should review the following information from the device's Instructions for Use: - Do not pull the Spiral Tip from the fetal skin. Do not pull the FSE wires apart. - Do not over-rotate Spiral Tip during attachment. - Inspect the Spiral Tip to ensure that it is still attached to the FSE Hub. If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique. Customers were provided with a reply form and asked to complete the form and return it to Philips: 1-877-499-7223 (eFax) or email to recall.response@philips.com. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377, option 2.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Distributed nationwide within US. Worldwide international distribution.

Timeline

Recall initiated: 2019-01-25
Terminated: 2020-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171593. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.