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WIPRO GE HEALTHCARE PRIVATE LIMITED · Model ULTRASOUND TRANSDUCER WATERTIGHT LOOP · UDI-DI 00840682104296

HFMHEL Prescription
1
510(k) clearances
41
Adverse events (3 deaths)
8
Recalls
13
Facilities

Recalls

DateFirmReason
2019-09-19Pacific Medical Group Inc.Fetal transducers distributed in advance of receiving 510(k) and international clearances.
2019-09-19Pacific Medical Group Inc.Fetal transducers distributed in advance of receiving 510(k) and international clearances. Possible adverse clinical impact: inability to accurately detect and measure fetal heart
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl
2019-09-11Pacific Medical Group Inc.Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.