FDA (Devices) recall action 97830
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
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.
B-K Medical is recalling 895 bk5000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 124 bk3500 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 496 bk3000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 1,697 Ultrasound System 1300 bkSpecto units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.