| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00217-1 |
| Product Name/Description |
Universal Arm Support
Product Names: Universal Arm Support 450 / 450T, 600 / 600T, 450U / 450U T
Model Numbers: 1697630, 1697635, 1697639, 1697651, 1697660, & 1697662.
Serial Numbers up to (respectively): 103106579, 103011318, 102631713, 102968819, 102956866, 102945650
Manufactured between May 2012 and Aug 25 2016
ARTG Number: 296295
(Trumpf Med Aust - Holder, patient, arm) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
During continuous monitoring and analysis of Trumpf Medical products installed in the field, some customers have reported that the Universal Arm Support may be unable to hold its set position and support the arm of the patient. Investigations indicates this is typically seen prior to initial use or during set-up, but the clamping could also deteriorate over time. The product has not been involved with any reported injuries. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Trumpf Medical is advising users to confirm all mechanical functions are parts are undamaged and in good working order prior to each use as outlined in the IFU.
In cases where it is identified that the device is defective, damaged, leaking oil or will not hold its set position, stop use of the device and contact Trumpf Medical: service.au@trumpfmedical.com to receive the replacement parts. Please ensure replaced part sare returned to Trumpf Medical.
This action has been closed out on the 21/11/2018. |
| Contact Information |
1800 445 576 - Trumpf Technical Support |