Recall Ledger

Philips Avalon Fetal Monitor recall (Philips North America Llc)

Medical deviceClass IIOngoing

Summary: Philips North America Llc is recalling Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A. Reason: 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.

What is being recalled

Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: California, Idaho, Illinois, Indiana)

How to tell if yours is affected

UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216,

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2522-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMay 26, 2026
ReportedJuly 1, 2026
CompanyPhilips North America Llc
Company locationCambridge, MA, United States
Initiated byVoluntary: Firm initiated
Quantity285 units

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