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Philips North America Llc: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

Medical DevicesSource: FDA (device) · Date: 2026-07-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America Llc
Product
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-05-26
Code info
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.
Product quantity
169 units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
99084
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