EKOS Recalls
6 recalls on record · July 25, 2012 to October 5, 2016 · Medical Devices
Recalls by year
12
13
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 5, 2016Medical DevicesFDA
EKOS Corporation recalls The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transp
Hazard: Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
September 28, 2016Medical DevicesFDA
EKOS Corporation recalls EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Hazard: The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
March 2, 2016Medical DevicesFDA
EKOS Corporation recalls EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic E
Hazard: The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
July 29, 2015Medical DevicesFDA
EKOS Corporation recalls The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MA
Hazard: The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.
November 13, 2013Medical DevicesFDA
EKOS Corporation recalls The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer)
Hazard: The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
July 25, 2012Medical DevicesFDA
EKOS Corporation recalls EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150
Hazard: EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.