Recall Z-2239-2024— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2024-05-22. It names one FDA 510(k) clearance: K140535. Product: Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.. Reason: Potential for inaccurate fetal heart rate measurements when monitoring multiples..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-22
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Reason for recall
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
Data sourced from openFDA. This site is unofficial and independent of the FDA.