Pacific Medical Ultrasound Transducers Recalled for Missing Clearances
Pacific Medical Group Inc. is recalling 678 fetal ultrasound transducers because they were distributed before receiving required FDA 510(k) 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 hazard is a regulatory compliance issue (distribution before clearance) rather than a direct physical defect causing injury, and no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pacific Medical Group Inc. is recalling 678 units of the GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260. The recall affects all serial numbers sold between January 21, 2015, and April 30, 2019.
The reason for the recall is that these fetal transducers were distributed in advance of receiving 510(k) and international clearances. The devices were distributed across 46 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 devices should stop using them and contact Pacific Medical Group Inc. for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 678
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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