Pacific Medical Ultrasound Transducers Recalled for Lack of FDA Clearance
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound Transducers because they were distributed before receiving required FDA 510(k) and international clearances.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or deaths. The hazard is regulatory (lack of clearance) rather than a confirmed physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Pacific Medical Group Inc. is recalling 295 units of the GE Corometrics Nautilus Ultrasound Transducer w/knob, model 5700HAX, FFCM5205. The recall involves all serial numbers sold between January 21, 2015, and April 30, 2019.
The recall was initiated because these fetal transducers were distributed in advance of receiving the required FDA 510(k) and international clearances. The devices were distributed across 44 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the United Arab Emirates.
Healthcare facilities and consumers who possess these specific transducers should stop using them immediately. Users should contact Pacific Medical Group Inc. for instructions on how to return the devices or obtain a refund.
The recalled product
- Product
- Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 295
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 sold between 01/21/2015 - 04/30/2019
Distribution
Part of a larger recall action
This product is one of 7 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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