The Recall Desk
SevereFDA (Devices)·Z-1168-2020·Announced 2020-02-19

Pacific Medical Toco MP Transducers Recalled for Non-OEM Components

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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves significant injury reports, specifically patient and clinician burns, as well as the risk of delayed detection of maternal or fetal distress.

Plain-English summary

Pacific Medical Group Inc. is recalling 1,776 Toco MP Transducers (M2734B) that may have been serviced or remanufactured using non-OEM equivalent components. These components have not been appropriately verified or validated. The affected units were distributed worldwide, including across the United States and in several international markets.

The recall is due to the potential for adverse clinical impacts resulting from the unverified components. These impacts include the inability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, and maternal blood pressure. Additionally, the defect may result in a lack of electrocardiography tracing, patient or clinician burns, and delays in detecting maternal or fetal distress.

Healthcare facilities and consumers should stop using the affected Toco MP Transducers immediately. Pacific Medical Group Inc. is the recalling firm and is responsible for managing the recall. Users should contact the manufacturer for instructions on how to return or replace the affected devices.

The recalled product

Product
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
Affected units
1,776

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers serviced between 9/2/15 and 4/2/19.

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Pacific Medical Group Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →