Recall Z-1403-2011 ยท HAW Neurological Stereotaxic Instrument
Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic mu
| Date | Feb 25, 2011 (initiated Nov 10, 2010) |
| Status | Terminated |
| Reason | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation. |
| Root cause | Software design |
| Action | Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all a |
| Quantity | 1,155 total |
| Distribution | Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062640 | STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 Stryker Instruments, Dec 14, 2006 |