FDA (Devices) recall action 97643
The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling the X7-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling one C9-4 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the 3D6-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the OMNI III TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the Mini Multi TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the S4-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the X3-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the L12-5 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling two OMNI II TEE Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling two L17-5 Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling one S5-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.