Events

Recall of Device Recall PercuNav, Tool Connection Unit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

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
    58993
  • Event Risk Class
    Class 2
  • Event Number
    Z-2769-2011
  • Event Initiated Date
    2011-06-01
  • Event Date Posted
    2011-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100799
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Percunav tool connection unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.
  • Action
    Philips Healthcare sent an "MEDICAL DEVICE CORRECTION" letter dated May 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The notification letter instructs customers to follow all directions in the Instructions for Use. A Philips Healthcare representative will schedule an appointment to replace the Tool Connection Unit at no charge to the customers. If further information is needed concerning this recall please call Philips Customer Service at 866-767-7822.

Device

Device Recall PercuNav, Tool Connection Unit
  • Model / Serial
    System Code Serial Numbers are: 03B8QR, B00DQ2, B00HZR, B00J3F, B00P3X, B00P3Y, B00P59, B00P5P, B00PB4, and B00PPP.   The Tool Connection Units with the following serial numbers are:  B00J0G, B00J0H, B00J0M, B00J0N, B00J0Q, B00J0R, B00J0X, B00J0Y, B00J10, and B00J20.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of CA, GA, OH, WA, and Washington DC, and the countries of Australia, India, Netherlands, and South Korea.
  • Product Description
    The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument. || The Tool Connection Unit is a component of the PercuNav Image Guided Intervention System. It is used to connect tracked instruments to the PercuNav system unit. || It has a System Part Number: 989605392501, 989605396032, 989605395201. || Tool Connection Unit Part Number: 453561426002, 453561443201 || The model number: Stand-alone PercuNav: TX2-120, PercuNav integrated on iV22: TXV2. || PercuNav is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-operative guidance for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device. The system can support a diagnostic mode in which fused images are used to help locate and evaluate targets visible on one modality on a second modality. The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to another.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA