Lower risk Medical device recall · FDA · Published May 22, 2024

Philips Avalon Ultrasound Transducer Recall: Inaccurate Fetal Heart Rate Measurements

Philips recalls Avalon Ultrasound Transducers with model 867246 that may give inaccurate fetal heart rate readings during multiple pregnancies. Affected units have specific serial numbers; contact Philips for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2239-2024Medical device Philips ›

Lower-risk recall

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling Avalon Ultrasound Transducers (model 867246) that may provide inaccurate fetal heart rate measurements when monitoring multiple fetuses. This could lead to incorrect pregnancy assessments. Read more at govinfonow.com/recall/55037-philips-avalon-ultrasound-transducer-recall-inaccurate-fetal-heart-rate-measurements.

Source Summary by GovInfoNow · govinfonow.com/recall/55037-philips-avalon-ultrasound-transducer-recall-inaccurate-fetal-heart-rate-measurements · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2239-2024

Cite this page

“Philips Avalon Ultrasound Transducer Recall: Inaccurate Fetal Heart Rate Measurements.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55037-philips-avalon-ultrasound-transducer-recall-inaccurate-fetal-heart-rate-measurements. Based on FDA recall #Z-2239-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2024%22&limit=1).

The FDA announced on May 22, 2024, that Philips North America LLC is recalling the Avalon Ultrasound Transducer due to a potential for inaccurate fetal heart rate measurements when monitoring multiples. Owners should contact Philips for a replacement unit.

How to tell if you have it

Brand: Philips
Product: Avalon Ultrasound Transducer
Model No.: 867246
UDI: 00884838093195
Serial Nos.: DE67535433 through DE67544415 (specific codes listed in record)
Quantity: 6,915 units

The hazard

The recall addresses the potential for inaccurate fetal heart rate measurements when monitoring multiples. The device directs a low-energy ultrasound beam toward the fetal heart to externally monitor fetal heart rate.

Context

GovInfoNow's records show Philips North America LLC has issued 129 other recalls since July 12, 2017. Recent similar product recalls include the Philips EPIQ Elite Ultrasound System Recall for inaccurate blood flow measurements (Aug. 7, 2026) and the Koven BiDop 3 Pocket Doppler recall regarding fetal use not being FDA-cleared (March 4, 2026).

How to tell if you have this one

Check for model number 867246 and serial numbers listed in the recall (e.g., DE67535433, DE67535436). The device is used for monitoring fetal heart rate during pregnancy.

Brand
Philips
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for model number 867246 and serial numbers listed in the recall (e.g., DE67535433, DE67535436).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT, AU, BA, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GI, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KE, KW, LB, LK, LS, LT, LU, LV, LY,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

May 22, 2024Firm started the recall
Jun 28, 2024FDA classified it Class II
Jul 10, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Philips recalls

Link to this recall

<a href="https://govinfonow.com/recall/55037-philips-avalon-ultrasound-transducer-recall-inaccurate-fetal-heart-rate-measurements">Philips Avalon Ultrasound Transducer Recall: Inaccurate Fetal Heart Rate Measurements (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2239-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2239-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.