Pacific Medical Group Recalls Ultrasound Transducers Serviced with Non-OEM Parts
Pacific Medical Group is recalling 6,481 Button-Style Ultrasound Transducers serviced with unverified non-OEM components. The defect may cause inaccurate fetal and maternal 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 recall is classified as FDA Class II and involves a medical device defect that can lead to significant injury, including patient/clinician burns and delayed detection of fetal or maternal distress.
Plain-English summary
Pacific Medical Group Inc. is recalling 6,481 Button-Style Ultrasound Transducers (Nautilus), 8-foot Cord 5700HAX. These devices were serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. The affected units were serviced between October 20, 2014, and April 2, 2019, and were distributed nationwide and in several international markets.
The recall is due to the potential for adverse clinical impacts resulting from the use of unverified components. These impacts include 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, or delay the detection of maternal or fetal distress.
Healthcare facilities and consumers who have these specific transducers should stop using them immediately. Users should contact Pacific Medical Group Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, 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
- 6,481
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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