510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2239-2024Class II

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

Philips North America LLC / initiated 2024-05-22 / Open, Classified
FDA source (opens on fda.gov)

Philips North America Llc began a recall of Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate on . FDA classified it as Class II and gives the reason as "Potential for inaccurate fetal heart rate measurements when monitoring multiples". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2239-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Philips North America LLC
Product
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Product code
HGM System, Monitoring, Perinatal
Reason for recall
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
FDA 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 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.
Quantity in commerce
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, PS, PT, QA, RE, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, VN, ZA.
Product codes and lots
Model No. 867246; UDI: 00884838093195; Serial No. DE67535433, DE67535436, DE67535443, DE67535447, DE67535452, DE67535462, DE67535463, DE67535464, DE67535470, DE67535471, DE67535474, DE67535476, DE67535479, DE67535480, DE67535483, DE67535484, DE67535487, DE67535488, DE67535499, DE67535502, DE67535507, DE67535508, DE67535518, DE67535521, DE67535523, DE67535527, DE67535529, DE67535530, DE67535533, DE67535536, DE67535538, DE67535540, DE67535542, DE67535546, DE67535547, DE67535556, DE67535562, DE67535564, DE67535566, DE67535569, DE67535570, DE67535572, DE67535574, DE67535580, DE67535581, DE67535584, DE67535587, DE67535589, DE67535591, DE67535592, DE67535598, DE67535604, DE67535605, DE67535606, DE67535623, DE67535636, DE67535646, DE67535667, DE67535711, DE67535712, DE67535717, DE67535718, DE67535721, DE67535731, DE67535732, DE67535736, DE67535740, DE67535746, DE67535754, DE67535755, DE67535759, DE67535761, DE67535826, DE67535830, DE67535831, DE67535856, DE67535860, DE67535864, DE67535873, 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DE67538919, DE67538921, DE67538924, DE67538933, DE67538950, DE67538952, DE67538992, DE67538993, DE67538996, DE67538998, DE67539000, DE67539002, DE67539005, DE67539008, DE67539009, DE67539014, DE67539017, DE67539020, DE67539030, DE67539032, DE67539039, DE67539071, DE67539083, DE67539090, DE67539094, DE67539100, DE67539103, DE67539136, DE67539144, DE67539153, DE67539172, DE67539186, DE67539193, DE67539197, DE67539206, DE67539213, DE67539226, DE67539258, DE67539292, DE67539293, DE67539295, DE67539302, DE67539303, DE67539304, DE67539306, DE67539313, DE67539316, DE67539317, DE67539319, DE67539333, DE67539341, DE67539343, DE67539349, DE67539351, DE67539352, DE67539356, DE67539393, DE67539407, DE67539438, DE67539477, DE67539494, DE67539505, DE67539590, DE67539622, DE67539639, DE67539641, DE67539667, DE67539673, DE67539686, DE67539695, DE67539707, DE67539708, DE67539713, DE67539718, DE67539720, DE67539737, DE67539765, DE67539767, DE67539774, DE67539776, DE67539785, DE67539799, DE67539800, 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Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2239-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2239-2024Class IIOngoingVoluntary: Firm initiated