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U.S. Department of Health and Human Services

Class 2 Device Recall PercuNav, Tool Connection Unit

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 Class 2 Recall
PercuNav, Tool Connection Unit
see related information
Date Posted July 09, 2011
Recall Status1 Terminated on February 15, 2012
Recall Number Z-2769-2011
Recall Event ID 58993
Premarket Notification
510(K) Number
K053610 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell, Washington 98021-8431
For Additional Information Contact Philips Healthcare
866-767-7822
Manufacturer Reason
for Recall
PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 10 units (6 in US and 4 internationally). This was later changed to 7 US and 3 International) all serial codes remain the same
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = TRAXTAL TECHNOLOGIES INC.
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