The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the pos
FDA device recall Z-2769-2011 · posted 2011-07-09 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2011-06-01
- Date posted
- 2011-07-09
- Date terminated
- 2012-02-15
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABARIS (K053610) | Traxtal Technologies, Inc. | 2006-04-19 |