Pacific Medical Nautilus Ultrasound Recalled for Missing Clearances
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound units because fetal transducers were distributed before receiving required FDA and international clearances.
What this means for you
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. The source text does not report any illnesses, injuries, or deaths, and the hazard is procedural (missing clearances) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Pacific Medical Group Inc. is recalling the GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660. The recall involves 4 units with serial numbers sold between January 21, 2015, and April 30, 2019.
The recall was initiated because fetal transducers were distributed in advance of receiving 510(k) and international clearances. The affected units were distributed in 45 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the United Arab Emirates.
Users of these devices should contact Pacific Medical Group Inc. for further instructions regarding the recall.
The recalled product
- Product
- Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
- Manufacturer
- Pacific Medical Group Inc.
- Category
- Medical Device — Ultrasound
- Affected units
- 4
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.
See all 7 products in this recall →Related recalls
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