Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts
Pacific Medical Group is recalling Loop-Style Ultrasound Transducers serviced with unverified non-OEM components. The parts 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 involves a Class II medical device with a risk of significant injury, including patient/clinician burns and delayed detection of fetal 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 Loop-Style Ultrasound Transducers (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with specific non-OEM equivalent components. These components have not been appropriately verified or validated. The recall involves 6,797 units distributed worldwide, including across the United States and in countries such as Canada, Mexico, and the United Kingdom.
The recall is due to the use of non-OEM parts that 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, cause patient or clinician burns, and delay the detection of maternal or fetal distress.
Healthcare facilities and consumers who possess these devices should stop using them immediately. Pacific Medical Group Inc. is the recalling firm and will provide further instructions on how to address the issue. The affected serial numbers are those serviced between December 18, 2014, and April 2, 2019.
The recalled product
- Product
- Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE…
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 6,797
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 12/18/14 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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