Z-2523-2026 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-2523-2026 was initiated by Philips North America Llc on May 26, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 169 units.

Recall Details

Product Type
Devices
Report Date
July 1, 2026
Initiation Date
May 26, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
169 units

Product Description

Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

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.

Distribution Pattern

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.

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.