Z-1250-2019 Class II Terminated
FDA device recall Z-1250-2019 was initiated by Philips North America, LLC on January 25, 2019 and is designated Class II. 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. The recall status is terminated (terminated December 8, 2020). Affected quantity: 1,971,925 (78,877 boxes).
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- January 25, 2019
- Termination Date
- December 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,971,925 (78,877 boxes)
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.
Distribution Pattern
Distributed nationwide within US. Worldwide international distribution.
Code Information
All products currently in distribution.