EKOS EkoSonic Control Unit Recalled for Missing AC Filter
EKOS Corporation is recalling EkoSonic Control Units because they have the incorrect power entry module installed and are missing an AC filter.
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. The hazard involves missing electrical components (AC filter) that could cause interference, but the source does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
EKOS Corporation is recalling one unit of the EkoSonic Control Unit. The recalled device is part of the EkoSonic Endovascular System, which uses ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and pulmonary arteries.
The recall is being issued because the Control Unit had the incorrect power entry module installed. Specifically, the unit is missing an AC filter that is required to reduce noise and electrical interference.
The affected unit is identified by the code PT3B-783, where PT3B is the model number and 783 is the serial number. The distribution pattern for this specific unit is listed as worldwide distribution in Germany only. Consumers and healthcare providers should stop using the affected unit and contact EKOS Corporation for instructions on how to proceed.
The recalled product
- Product
- The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The…
- Manufacturer
- EKOS Corporation
Distribution
Distribution scope not specified by the agency.
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