EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure
EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.
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, but the source text describes a functional defect (cable not recognized) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
EKOS Corporation is recalling 46 units of the EKOS EkoSonic Control Unit. The recall is due to a defect where the Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. The affected units were distributed nationwide.
The EKOS EkoSonic Control Unit is a reusable component of the EkoSonic Endovascular System, intended for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The system uses ultrasound energy to disperse fluid into the intravascular treatment site. The recalled units are identified by specific CIC serial numbers listed in the agency's recall notice.
Healthcare providers and users of these devices should stop using the affected units and contact EKOS Corporation for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised
- Manufacturer
- EKOS Corporation
- Hazard
- Affected units
- 46
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 (20)
- CIC Serial Numbers: 19598-095
- 19598-097
- 19598-099
- 19598-100
- 19598-102
- 19598-103
- 19598-106
- 19598-107
- 19598-108
- 19598-110
- 19598-111
- 19598-112
- 19598-113
- 19598-114
- 19598-115
- 19598-116
- 19598-117
- 19598-118
- 19598-119
- 19598-120
Distribution
Distributed nationwide across the United States.
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