Recall Z-2239-2024 ยท HGM System, Monitoring, Perinatal
Philips North America Llc
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
| Date | Jun 28, 2024 (initiated May 22, 2024) |
| Status | Open, Classified |
| Reason | Potential for inaccurate fetal heart rate measurements when monitoring multiples. |
| Root cause | Component change control |
| Action | An URGENT MEDICAL DEVICE CORRECTION notice dated 5/22/2024 was mailed to consignees. Consignees are instructed to identify what software their Avalon wired transducers. Avalon wired transducers with software revision L.01.04 must not be used when monitoring multiples and can only be safely used when monitoring the fetal heart rate of singletons. Avalon wired transducers that do not possess the affected software revision can be used when monitoring twins or triplets. An alternative to the Avalon wired Transducer is using the wireless Avalon CL Ultrasound transducer. Consignees are to complete a |
| Quantity | 6,915 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AD, AE, AR, AT, AU, BA, BE, BG, BH, BO, BR, CH, CL, CO, CY, CZ, DE, DZ, EG, ES, FI, FR, GB, GI, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KE, KW, LB, LK, LS, LT, LU, LV, LY, MA, ME, MT, MU, MY, NA, NI, NL, NZ, OM, PA, PH, PK, PL, PR, |
| 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 |