FDA (Devices) recall action 83610
The FDA (Devices) publishes a recall like this one as 10 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 10 pages.
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
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.
Pacific Medical Group Inc. is recalling Toco MP Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal monitoring and patient burns.
Pacific Medical Group is recalling 1,994 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate fetal and maternal monitoring.
Pacific Medical Group is recalling 466 Toco M2734A fetal monitors serviced with unverified non-OEM components that may fail to detect fetal distress or cause burns.
Pacific Medical Group is recalling 2,170 Toco+ transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal/maternal monitoring and patient burns.
Pacific Medical Group is recalling 6,481 Button-Style Ultrasound Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal and maternal monitoring or patient burns.
Pacific Medical Group is recalling 5,897 ultrasound transducers serviced with unverified non-OEM components, which may cause inaccurate monitoring or patient burns.
Pacific Medical Group is recalling Loop-Style Tocotransducers serviced with unverified non-OEM components, which may cause inaccurate fetal monitoring or patient burns.
Pacific Medical Group is recalling Loop-Style Ultrasound Transducers serviced with unverified non-OEM components. The parts may cause inaccurate fetal monitoring and patient burns.
Pacific Medical Group is recalling 1,603 External Toco Transducers serviced with non-OEM parts that were not appropriately verified or validated.
Pacific Medical Group is recalling 9,679 Button-Style Tocotransducers serviced with non-OEM components that were not appropriately verified, posing risks of inaccurate monitoring and burns.