Philips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall
Philips is recalling certain Avalon Fetal Monitor FM20 units worldwide due to incorrect speaker connector assembly that can cause device cables to be pulled out, leading to loss of speaker output.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported injuries or illnesses. The defect presents a risk of device malfunction (loss of audio output) but the source text does not indicate any actual harm has occurred or any risk of serious injury.
Plain-English summary
Philips North America LLC is recalling the Avalon Fetal Monitor, FM20 (Part numbers M2702A and M2703A), due to an assembly defect affecting the speaker connector. The affected units have incorrect assembly of the speaker connector, which can cause device cables to be pulled out of the housing.
This defect increases the risk of intermittent or permanent loss of speaker output. The recall affects 285 units that have been distributed worldwide, including throughout the US and internationally to the following countries: 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, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, and ZA.
Consumers who have received one of the affected units should contact Philips North America LLC for instructions on how to address this issue. The recalled device carries UDI/DI 00884838000407, and affected serial numbers are listed in the FDA recall notice.
The recalled product
- Product
- Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
- Manufacturer
- Philips North America Llc
- Affected units
- 285
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00884838000407
- Serial Numbers: DE79569306
- DE79569332
- DE79569360
- DE79569417
- DE79569442
- DE79569482
- DE79569307
- DE79569470
- DE79569390
- DE79569356
- DE79569452
- DE79569289
- DE79569302
- DE79569536
- DE79569358
- DE79569343
- DE79569457
- DE79569353
- DE79569373
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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