VL13-5 Transducer Probe
FDA Recall #Z-2405-2025 — Class III — July 3, 2025
Product Description
VL13-5 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. 989605409592, 989605439931; UDI: (01)00884838061606(21)B2LKRC, (01)00884838061606(21)B1RY95, (01)00884838061606(21)B26B50, (01)00884838061606(21)B29K57, (01)00884838061606(21)B1GK0X, (01)00884838061606(21)B285DN, (01)00884838061606(21)B285DP, (01)00884838061606(21)B2865W, (01)00884838061606(21)B2DW9V, (01)00884838061606(21)B252D1, (01)00884838061606(21)B20XP7, (01)00884838061606(21)F010PF, (01)00884838061606(21)B2865X, (01)00884838061606(21)B20YTN, (01)00884838061606(21)B21T6J, (01)00884838061606(21)B2281P, (01)00884838061606(21)B2G3L0, (01)00884838061606(21)B29DGY, (01)00884838061606(21)B285DQ, (01)00884838061606(21)B1TW50, (01)00884838061606(21)B289V9, (01)00884838061606(21)B1PK9D, (01)00884838061606(21)B1QRX1, (01)00884838061606(21)B33XYT, (01)00884838061606(21)B1QC2H; Serial No. B2LKRC, B1F5NL, B1RY95, B26B50, B29K57, B1C5HY, B1GK0X, B285DN, B285DP, B2865W, B13D9W, B1C5R3, B1F0N7, B2DW9V, B252D1, B20XP7, F010PF, B2865X, B20YTN, B21T6J, B2281P, B2G3L0, B29DGY, B285DQ, B1BNHV, B1TW50, B289V9, B1FB5H, B1F5TD, B1FWDK, B1PK9D, B1FZ0T, B1QRX1, B33XYT, B1QC2H, B1B6RT, B1C20Z.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated