| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00619-1 |
| Product Name/Description |
Navigational System II - Cart
(Surgical navigation system)
Catalogue number: 7700-100-000
Cart Serial Number: 100968, 100969
Arm Serial Number: 11102258470, 11102258469
ARTG Number: 127497 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Between May 2012 and July 2014, Ondal Medical Systems GmbH received three complaints from customers where a broken joint of the articulated arm was reported. For two of the complaints the parts failed directly after installation of the device, for the other complaint, the part failed after six months. The load attached to the arm was in all three cases was approximately 18 kg.
Additional inspection is required because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is requesting hospitals to check all stock areas and/or operating room storage and quarantine all affected equipment. A Stryker Representative will contact your facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera. This action has been closd-out on 15/08/2016. |
| Contact Information |
1800 803 601 RAQA Coordinator |