Z-2148-2015 Class II Terminated
FDA device recall Z-2148-2015 was initiated by EKOS Corporation on June 24, 2015 and is designated Class II. Reason for recall: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. The recall status is terminated (terminated August 25, 2015). Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- June 24, 2015
- Termination Date
- August 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
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 of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
Reason for Recall
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
Distribution Pattern
Nationwide Distribution
Code Information
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, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158.