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FDA (Device enforcement)Recalled 2025-07-03class iii

Philips Ultrasound, Inc: L15-7io Transducer Probe

Hazard

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Details from the source

Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Distribution: US Nationwide distribution. Quantity: 171,322 units Lot/code info: Model No. 989605387852, 989605438421, 989605387341, 989605428532, 989605391083, 989605412042, 989605412082, 989605418963, 989605387851; UDI: (01)00884838061491(21)B2Y4MR, (01)00884838061491(21)B2YR9K, (01)00884838061491(21)F0DWM3, (01)00884838061491(21)F084NQ, (01)00884838061491(21)F0D244, (01)00884838061491(21)F0F19W, (01)00884838061491(21)F0G2RJ, (01)00884838061491(21)F0K6X7, (01)00884838087057(21)B2C14V, (01)00884838061491(21)B1PJC0, (01)00884838061491(21)B24YWK, (01)00884838061491(21)F0L51D, (01)00884838061491(21)F0L51F, (01)00884838061491(21)B31Q0J, (01)00884838061491(21)B3KQTR, (01)00884838061491(21)B2KLR3, (01)00884838061491(21)B2KLZ4, (01)00884838061491(21)B3H0PX, (01)00884838061491(21)B3J6LC, (01)00884838061491(21)F03BYJ, (01)00884838061491(21)F046Q9, (01)00884838061491(21)F04L49, (01)00884838061491(21)F0CXV3, (01)00884838061491(21)F0D5LN, (01)00884838061491(21)B1WGZP, (01)00884838061491(21)F03WVP, (01)00884838061491(21)F044Z4, (01)00884838073623(21)F041TJ, 010088483806149121F025Z4, (01)00884838061491(21)F002TP, (01)00884838061491(21)F06BF7, (01)00884838061491(21)F06C7C, (01)00884838061491(21)F06CWM, (01)00884838061491(21)F06FP7, (01)00884838061491(21)F06GLG, (01)00884838061491(21)F0CZ2Z, (01)00884838061491(21)F0D6R6, 010088483806149121F0G7MD, (01)00884838061491(21)B285T6, (01)00884838061491(21)F00ZL7, (01)00884838061491(21)F0101H, (01)00884838061491(21)F010NB, (01)00884838061491(21)B2QGT2, (01)00884838061491(21)B2X20Q, (01)00884838061491(21)B2YYTP, (01)0088483806149

UPC codes

989605387852, 989605438421, 989605387341, 989605428532, 989605391083, 989605412042, 989605412082, 989605418963, 989605387851, 00884838061491, 00884838087057, 00884838073623, 00884838067516, 00884838061613, 00884838061637, 0088483806149

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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