Z-2522-2026Class II

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

Name: Z-2522-2026 Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Creator: Philips North America Llc
Published: 2026-05-26
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-05-26 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A on 2026-05-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2522-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-26
Posted: 2026-06-22
Recalling firm: Philips North America LLC
Product: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Product code: HGM System, Monitoring, Perinatal
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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."
Quantity in commerce: 285 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2522-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2522-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-22
Z-2523-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-22

Product code HGM

K140535Class IIPhilips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 and Fm50Philips Medizin Systeme Boblingen GmbH / cleared 2014-11-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)