Pacific Medical Toco+ Transducers Recalled for Unverified Service Components
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly lists 'patient/clinician burns' as a possible adverse clinical impact, which aligns with the rubric criterion for 'significant injury' reports, warranting a score of 4.
Plain-English summary
Pacific Medical Group Inc. is recalling 2,170 Toco+ transducers with ECG/IUP capability (wired) that may have been serviced with specific non-OEM equivalent components. The affected units were serviced between September 2, 2015, and April 2, 2019, and were distributed worldwide, including in the United States and various international locations.
The recall is due to the use of non-OEM components that have not been appropriately verified or validated. This defect may result in the inability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, or maternal blood pressure. Additionally, the defect may cause 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 transducers immediately. Pacific Medical Group Inc. is the recalling firm and is responsible for managing the recall process for these devices.
The recalled product
- Product
- Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 2,170
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
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.
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