Class 2 Device Recall Philips Avalon

• Date Initiated by Firm: May 26, 2026
• Date Posted: June 22, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2523-2026
• Recall Event ID: 99084
• 510(K)Number: K140535
• Product Classification: System, monitoring, perinatal - Product Code HGM
• Product: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
• Code Information: UDI/DI 00884838000414, Serial Numbers: DE79646555, DE79646616, DE79646645, DE79646647, DE79646651, DE79646697, DE79646702, DE79646746, DE79646754, DE79646757, DE79646758, DE79646762, DE79646765, DE79646775, DE79646776, DE79646783, DE79646857, DE79646891, DE79646924, DE79646750, DE79646751, DE79646756, DE79646804, DE79646592, DE79646877, DE79646644, DE79646706, DE79646723, DE79646653, DE79646766, DE79646786, DE79646824, DE79646827, DE79646848, DE79646956, DE79646709, DE79646892, DE79646724, DE79646729, DE79646732, DE79646733, DE79646927, DE79646675, DE79646820, DE79646821, DE79646837, DE79646866, DE79646869, DE79646871, DE79646875, DE79646882, DE79646683, DE79646676, DE79646640, DE79646849, DE79646952, DE79646699, DE79646694, DE79646648, DE79646701, DE79646900, DE79647027, DE79647039, DE79646654, DE79646800, DE79646604, DE79646660, DE79646829, DE79646747, DE79646606, DE79646826, DE79646784, DE79646794.
• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 800-722-9377
• Manufacturer 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.
• FDA Determined 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: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HGM