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Avalon TOCO MP Transducer

Philips Medizin Systeme Böblingen GmbH · Model Avalon TOCO MP Transducer · UDI-DI 00884838021471

HFM Prescription

510(k) clearances

Adverse events (3 deaths)

Recalls

Facilities

Description

Toco MP Transducer including Toco and maternal Pulse Measurement

Recalls

Date	Firm	Reason
2019-09-19	Pacific 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
2019-09-19	Pacific Medical Group Inc.	Fetal transducers distributed in advance of receiving 510(k) and international clearances.
2019-09-11	Pacific 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
2019-09-11	Pacific 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
2019-09-11	Pacific 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
2019-09-11	Pacific 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
2019-09-11	Pacific 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
2019-09-11	Pacific 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.