Recall Z-2769-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems North America Co. Phillips
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, 9896
| Date | Jul 9, 2011 (initiated Jun 1, 2011) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 10 units (6 in US and 4 internationally). This was later changed to 7 US and 3 International) all serial codes remain t |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053610 | ABARIS Traxtal Technologies, Inc., Apr 19, 2006 |