FDA-Device2026-07-01Class IIPROCESSING DEFECT

Philips Avalon Fetal Monitor FM 30 recalled for speaker connector assembly defect

OTHERNationwide distributionMedical devices

What this means

Certain Philips Avalon FM 30 fetal monitors have an incorrect speaker connector assembly that can allow device cables to be pulled out of the housing. This defect may cause the speaker to stop working intermittently or permanently, which could affect audio output during monitoring.

  • Check if your Philips Avalon FM 30 serial number matches the affected list
  • Contact Philips North America LLC for instructions on inspection or replacement
  • Do not force cables in or out of the speaker connector housing
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The agency's original wording
Hazard

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.

Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
169 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2523-2026

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