Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal he

FDA device recall Z-2239-2024 · posted 2024-06-28 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

Potential for inaccurate fetal heart rate measurements when monitoring multiples.

Action taken

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 and return the provided response form at recall.responsephilips.com or by fax to 877-499-7223. The provided recall notification should be shared with all clinical staff and kept with the documentation of the Avalon ultrasound transducer. Consignees with questions should contact their local Philips representative or call 1-800-722-9377.

Root cause

Component change control

Status

Open, Classified

Product code

HGM

Quantity affected

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,

Date initiated

2024-05-22

Date posted

2024-06-28

Location

Cambridge, MA

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