Events

Recall of Device Recall Accu2i pMTA Applicator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77631
  • Event Risk Class
    Class 2
  • Event Number
    Z-0530-2018
  • Event Initiated Date
    2017-06-05
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156983
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, ablation, microwave and accessories - Product Code NEY
  • Reason
    The firm is recalling product that has the potential to not function during use. the product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code high reflective power displayed on the microwave generator.
  • Action
    URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken.

Device

Device Recall Accu2i pMTA Applicator
  • Model / Serial
    Lots: 15330421, 15340426, 15370438, 15390447, 15400452, 15430458, 15440462, 15450465, 15480475, 15500482, 15520486, 16060497, 16100507, 16130516, 16140519, 16160526, 16180532, 16190537, 16240553, 16330580, 16350583, 16380594, 16410601, 16420607,  16430608, 16440616, 16460623, 16480629, 16500639, 17020652, 17090671, 17140694.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide
  • Product Description
    Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. || Product Usage: || The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA