Recall Z-2523-2026 ยท HGM System, Monitoring, Perinatal
Philips North America Llc
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
| Date | Jun 22, 2026 (initiated May 26, 2026) |
| Status | Open, Classified |
| 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. |
| 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 organiz |
| Quantity | 169 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 Philips Medizin Systeme Boblingen GmbH, Nov 25, 2014 |