| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01019-1 |
| Product Name/Description |
Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)
Product numbers: 0682001270, 0682001274, 0682000226 & 06824000591
Multiple lot numbers affected
ARTG Number: 118878 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable AC3000 Spring Arm and fallen down together with the monitor until it was only held by the electrical cable connections. An inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. Investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. The frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker Service Technician to inspect and correct Spring Arm Circlips. |
| Contact Information |
02 9467 1106 - Sofie Parker |