Pacific Medical External Toco Transducers Recalled for Unverified Components
Pacific Medical Group is recalling 1,603 External Toco Transducers serviced with non-OEM parts that were not appropriately verified or validated.
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 a risk of patient/clinician burns and failure to detect fetal/maternal distress, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Pacific Medical Group Inc. is recalling 1,603 units of the External Toco Transducer (M1355A) that may have been serviced or remanufactured using non-OEM equivalent components. These components have not been appropriately verified or validated. The affected units are those serviced between October 20, 2014, and April 2, 2019.
The recall is due to the potential inability of the devices to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, or maternal blood pressure, as well as the lack of electrocardiography tracing. The source text also notes a risk of patient or clinician burns and a delay in detecting maternal or fetal distress.
The affected devices were distributed worldwide, including nationwide in the United States and in specific countries such as Belgium, Argentina, Mexico, Canada, and others. Healthcare facilities and consumers should stop using these devices and contact Pacific Medical Group Inc. for further instructions.
The recalled product
- Product
- External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 1,603
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 10/20/14 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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