Pacific Medical Toco M2734A Fetal Monitors Recalled for Unverified Components
Pacific Medical Group is recalling 466 Toco M2734A fetal monitors serviced with unverified non-OEM components that may fail to detect fetal distress or cause 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 the source text explicitly lists 'patient/clinician burns' as a possible adverse clinical impact, which aligns with the rubric criteria for Severe (Class II with injury reports).
Plain-English summary
Pacific Medical Group Inc. is recalling 466 units of the Toco M2734A fetal/maternal monitor. These devices may have been serviced or remanufactured using non-OEM equivalent components that were not appropriately verified or validated. The recall covers units serviced between September 2, 2015, and April 2, 2019, which were distributed nationwide in the United States and in various countries worldwide.
The use of unverified components 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 devices may lack electrocardiography tracing. The recall notice also identifies a risk of patient or clinician burns and a potential delay in detecting maternal or fetal distress.
Healthcare facilities and consumers should stop using the affected Toco M2734A monitors immediately. Pacific Medical Group 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 M2734A, 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
- 466
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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