| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00590-1 |
| Product Name/Description |
Ceiling Supply Unit klinoPORT
klinoPORT 706 M, 806 M, 906 M , 1006 M, 1306M
Item Numbers: 4027210, 4027410 and 4027510
Serial Numbers: 100775185 to 101040245
Only motorised height-adjustable arms are affected by this recall (recognisable by the letter "M" in the product name) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Trumpf Medical has been notified of an incident where a motorised height-adjustable arm of a klinoPORT ceiling supply unit suddenly and abruptly fell to its lowest position. The cause analysis revealed that the welded connections of the drive did not comply with the specified condition and therefore led to breakage of these connections. It is currently not to be ruled out that further drives within the same serial numbers range may have the same fault. If further cases should occur, the risk of severe injury to persons cannot be ruled out. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Trumpf Medical will replace all potentially affected components in order to prevent a repetition of this incident. Until the correction can be made end users are advised to ensure that the unit is in the lowest position. Trumpf is recommending that a warning be placed on the device or the electrical fuse removed to ensure that the height of the arm is not adjusted. This action has been closed-out on 08/08/2016. |
| Contact Information |
02 6406 8900 - Trumpf Medical |