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Philips Avalon Fetal Monitor, FM 30 Part numberM2703A recallZ-2523-2026 · Philips North America Llc · initiated May 26, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

FDA root cause category: Process control

What the company is doing

Philips issued an URGENT Medical Device Correction notice to its consignees on 5/26/2026 via USPS certified mail. The notice explained the issue and how it can be identified, potential risk to the patient should the loss of audio is not detected, and requested the following: "Actions that should be taken by the customer / user in order to prevent risks for patients or users " Ensure fetal heart rate tones are enabled on the Avalon Fetal Monitor until the planned fix/correction is implemented. " Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. " Place this Urgent Medical Device Correction with the documentation of the Philips Avalon Fetal Monitor and associated devices in a place where it is most likely to be seen and viewed."

Recall details

Recall number
Z-2523-2026
Status
Open, Classified
Initiated by the company
May 26, 2026
Posted by the FDA
Jun 22, 2026
Recalling firm
Philips North America Llc
Quantity
169 units
Product code
HGM
FDA submissions
K140535
Distribution
Worldwide distribution - 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, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.

Product description

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI/DI 00884838000414, Serial Numbers: 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.

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 99084).

Sources and updates

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