Philips Avalon Fetal Monitor Recall Issued

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Philips North America Llc is recalling 169 units of the Philips Avalon Fetal Monitor, FM 30 (Part number M2703A) due to incorrect speaker connector assembly.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 5, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Medical Devices.

What Happened

Philips North America Llc initiated a voluntary recall of the Philips Avalon Fetal Monitor, FM 30 after determining that the monitor has incorrect assembly of the speaker connector. This can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Which Products Are Affected

The recall affects the Philips Avalon Fetal Monitor, FM 30, Part number M2703A. A total of 169 units are involved. The product has UDI/DI 00884838000414. Affected serial numbers include: DE79646555, DE79646616, DE79646645, DE79646647, DE79646651, DE79646697, DE79646702, DE79646746, DE79646754, DE79646757, DE79646758, DE79646762, DE79646765, DE79646775, DE79646776, DE79646783, DE79646857, DE79646891, DE79646924, DE79646750, DE79646751, DE79646756, DE79646804, DE79646592, DE79646877, DE79646644, DE79646706, DE79646723, DE79646653, DE79646766, DE79646786, DE79646824, DE79646827, DE79646848, DE79646956, DE79646709, DE79646892, DE79646724, DE79646729, DE79646732, DE79646733, DE79646927, DE79646675, DE79646820, DE79646821, DE79646837, DE79646866, DE79646869, DE79646871, DE79646875, DE79646882, DE79646683, DE79646676, DE79646640, DE79646849, DE79646952, DE79646699, DE79646694, DE79646648, DE79646701, DE79646900, DE79647027, DE79647039, DE79646654, DE79646800, DE79646604, DE79646660, DE79646829, DE79646747, DE79646606, DE79646826, DE79646784, DE79646794. Distribution was worldwide, including US Nationwide and the countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA. The recall number is Z-2523-2026. Classification is Class II. Recall initiation date was May 26, 2026.

What You Should Do

Consumers with affected units should contact the recalling firm, Philips North America Llc, at 222 Jacobs St, Cambridge, MA 02141-2289 for further information regarding the recall.

Why This Matters

The recall involves 169 fetal monitors distributed worldwide, addressing a defect that may lead to loss of speaker output.

Source

FDA recall number Z-2523-2026 (https://www.fda.gov)

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips North America Llc is recalling 169 units of the Philips Avalon Fetal Monitor, FM 30 (Part number M2703A) due to incorrect speaker connector assembly.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.