L12-5 38mm Transducer Probe
FDA Recall #Z-2375-2025 — Class III — July 3, 2025
Product Description
L12-5 38mm 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. 989605428532; UDI: (01)00884838073623(21)B305XD, (01)00884838073623(21)F05R7X, (01)00884838073623(21)B1Y35V, (01)00884838073623(21)B305ZX, (01)00884838073623(21)F05K8W, (01)00884838073623(21)B3GWRJ, (01)00884838073623(21)B1Y306, (01)00884838073623(21)B1Y3CG, (01)00884838073623(21)B1Q699, (01)00884838073623(21)B1Y3C4, (01)00884838073623(21)B1RXWK, (01)00884838073623(21)B305X5, (01)00884838073623(21)B305ZK, (01)00884838073623(21)B3NFD5, (01)00884838073623(21)F034C6; Serial No. B305XD, F05R7X, B1Y35V, B305ZX, F05K8W, B3GWRJ, B1Y306, B1Y3CG, B1Q699, B1Y3C4, B1RXWK, B305X5, B305ZK, B3NFD5, F034C6.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated