Pacific Medical Loop-Style Tocotransducers Recalled for Unverified Service Components
Pacific Medical Group is recalling Loop-Style Tocotransducers serviced with unverified non-OEM components, which may cause inaccurate fetal monitoring or 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' and 'delay in detecting maternal or fetal distress' as possible adverse clinical impacts. Per the rubric, significant injury reports or risks (burns) in a Class II recall warrant a score of 4 (Severe).
Plain-English summary
Pacific Medical Group Inc. is recalling approximately 10,911 Loop-Style Tocotransducers (Nautilus) 2264LAX. These devices may have been serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. The recall includes specific service parts such as the Nautilus Toco Board, TOCO Bottom Case, TOCO Cable Assembly, and TOCO Coil with Screws.
The recall is due to the risk that the unverified components may cause the device to fail to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, or maternal blood pressure. Additionally, the devices may lack electrocardiography tracing, cause patient or clinician burns, or delay the detection of maternal or fetal distress.
The affected units were distributed worldwide, including nationwide in the United States and in various international locations. The recall covers all serial numbers serviced between January 19, 2015, and April 2, 2019. Users should contact Pacific Medical Group for further instructions on how to address the affected devices.
The recalled product
- Product
- Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable…
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 10,911
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 1/19/15 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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