Philips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
Philips is recalling 169 units of the Avalon Fetal Monitor FM 30 due to incorrect speaker connector assembly that can cause device cables to disconnect, resulting in 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device where loss of speaker output on a fetal monitor creates a risk of harm (inability to alert clinicians to critical information) without reported injuries or illnesses. The hazard is functional failure affecting patient monitoring capability.
Plain-English summary
Philips North America LLC is recalling 169 units of the Avalon Fetal Monitor, FM 30 (Part number M2703A, UDI/DI 00884838000414). The device has 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 recalled units have been distributed worldwide, including throughout the United States and to multiple countries.
Customers with affected units should contact Philips North America LLC for instructions regarding the faulty equipment.
The recalled product
- Product
- Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- Manufacturer
- Philips North America Llc
- Affected units
- 169
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 00884838000414
- Serial Numbers: DE79646555
- DE79646616
- DE79646645
- DE79646647
- DE79646651
- DE79646697
- DE79646702
- DE79646746
- DE79646754
- DE79646757
- DE79646758
- DE79646762
- DE79646765
- DE79646775
- DE79646776
- DE79646783
- DE79646857
- DE79646891
- DE79646924
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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