C6-3 Transducer Probe
FDA Recall #Z-2356-2025 — Class III — July 3, 2025
Product Description
C6-3 Transducer Probe
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Recalling Firm
Philips Ultrasound, Inc — Reedsville, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
171,322 units
Distribution
US Nationwide distribution.
Code Information
Model No. 989605359593, 989605387371, 989605359594, 989605359591; UDI: (01)00884838067950(21)B20N4N, (01)00884838067950(21)B1WR9H, (01)00884838067950(21)B1RGN0, (01)00884838067950(21)B1MTT4, (01)00884838067950(21)B1N3C4, (01)00884838087170(21)B27LPZ, (01)00884838087170(21)B3W5CM, (01)00884838067950(21)B24KL3, (01)00884838067950(21)B1MTT5, (01)00884838087170(21)B27LQ2; Serial No. B20N4N, B1WR9H, B1RGN0, B1MTT4, B16QBM, B1N3C4, B27LPZ, 03DG3C, B3W5CM, B2ZN6B, B19M3K, B2TJFT, B35M7F, B24KL3, B1MTT5, B32P04, B35MC6, B27LQ2.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated