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.
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 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
- Manufacturer
- Pacific Medical Group Inc.
- 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
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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