FDA (Devices) recall action 83869
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Fetal transducers distributed in advance of receiving 510(k) and international clearances. 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 interruption of monitoring due to device failure that could lead to 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 261 fetal transducers distributed in the U.S. and abroad before receiving required FDA and international clearances.
Pacific Medical Group is recalling 772 fetal transducers distributed in the U.S. and abroad before receiving required FDA 510(k) and international clearances.
Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.
Pacific Medical Group Inc. is recalling 678 fetal ultrasound transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound Transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Pacific Medical Group Inc. is recalling 225 ultrasound transducers distributed before receiving required FDA and international clearances.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound units because fetal transducers were distributed before receiving required FDA and international clearances.