Philips Ultrasound, Inc: C8-5 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. 989605391922, 989605438441, 989605440822, 989605387852, 989605387281, 989605391092, 8500-1664-01, 989605352343, 989605352342; UDI: (01)00884838061514(21)B1Q41K, (01)00884838061514(21)B1QB9Z, (01)00884838061514(21)B2859G, (01)00884838061514(21)B2YTR3, (01)00884838061514(21)B2YTTV, (01)00884838061514(21)B3F4JN, (01)00884838061514(21)F08DZC, 010088483806151421F01W6L, (01)00884838061514(21)F04XX6, (01)00884838061514(21)F0FCL7, (01)00884838061514(21)B3B4RD, (01)00884838061514(21)B288HM, (01)00884838061514(21)B2FXYD, (01)00884838061514(21)B2FXZB, (01)00884838061514(21)B1P4JM, (01)00884838061514(21)B1P9ZG, (01)00884838061514(21)B338L3, (01)00884838061514(21)F0C7VZ, (01)00884838061514(21)F0FHNV, (01)00884838061514(21)F0KM0Y, (01)00884838061514(21)B22GYC, (01)00884838061514(21)B21T06, (01)00884838067691(21)B26NBY, (01)00884838061514(21)B34J00, (01)00884838061514(21)B2FXJK, (01)00884838067691(21)B2882D, (01)00884838067691(21)B288VM, (01)00884838067691(21)B2FY2G, (01)00884838061514(21)B2YH6Z, (01)00884838061514(21)B30Q8X, 010088483806151421F0G4ZF, (01)00884838061514(21)F011BM, (01)00884838061514(21)B1QBW2, (01)00884838061514(21)B1QTN7, (01)00884838061514(21)B1QTVX, (01)00884838061514(21)B2YGHZ, (01)00884838061514(21)F018FW, (01)00884838061514(21)B37W7W, (01)00884838061514(21)B22NLJ, (01)00884838067691(21)B338F0, (01)00884838061514(21)B216LD, (01)00884838061514(21)F0B6W5, (01)00884838061514(21)B287ZV, (01)00884838061514(21)B288BD, (01)00884838061514(21)B29XXK, (01)0088483806151

UPC codes

989605391922, 989605438441, 989605440822, 989605387852, 989605387281, 989605391092, 989605352343, 989605352342, 00884838061514, 00884838067691, 00884838061491, 00884838061507, 00884838061750

Source

Official record: FDA (Device enforcement) ↗

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