Philips Fetal Spiral Electrode-intended for patients… recallZ-0908-2023 · Philips North America Llc · initiated Nov 21, 2022

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Philips Medical issued to U.S. customers, the Urgent Medical Device Correction (UMDC) letter via certified mail 11/21/22. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take. Philips has decided to discontinue the distribution of this product. To limit the potential for the spiral tip of the FSE to break off in the patient s scalp, it is important to avoid over rotation during attachment or pulling the tip from the fetal scalp Customer should complete the Urgent Field Safety Notice Response Form online to submit both their acknowledgement of this recall (mandatory) and actions taken, as well as request for credit (optional). To request credit go to URL: https://forms.office.com/r/GsLVh2gYZi Pass this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (If appropriate). If you choose, discard all FSEs sold by Philips and source from an alternative supplier available in your country. If you choose to discard the FSEs, we will issue a credit after you complete the online response form. Actions planned by Philips Hospital Patient Monitoring to correct the problem " Philips is continuing to investigate additional root causes with FSE supplier " Philips will immediately discontinue selling the FSEs " Philips will reimburse for any discarded FSEs

Recall details

Recall number

Z-0908-2023

Status

Open, Classified

Initiated by the company

Nov 21, 2022

Posted by the FDA

Jan 6, 2023

Recalling firm

Philips North America Llc

Quantity

69,679 cases (1,741,975 units)

Product code

HGP

FDA submissions

K030691

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.

Product description

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Fetal Measurements FETAL SPIRAL ELECTRODE

  Philips Medical Systems Hsg · ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
  1 recall1 death92 reports

Other devices under the same FDA submission

1 device cleared under K030691 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Spiral Fetal Scalp Electrode CNS000004

  Clinical Innovations, LLC · Electrode, Circular (Spiral), Scalp And Applicator
  10 reports