Recall Z-1250-2019 ยท HGP Electrode, Circular (Spiral), Scalp And Applicator
Philips North America, LLC
Fetal Spiral Electrode, Model No. 9898 031 37631
| Date | Jan 25, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 t |
| Quantity | 1,971,925 (78,877 boxes) |
| Distribution | Distributed nationwide within US. Worldwide international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 Clinical Innovations, Inc., Sep 17, 2003 |