| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00209-1 |
| Product Name/Description |
IMRIS ORT100 and ORT300 Operating Room Tables
Part Numbers: 110470-000 and 114093-000
Serial Numbers: 10003241 and 10002255
ARTG Number: 276861
(Emergo Asia Pacific - Table, x-ray system, diagnostic, general-purpose, powered) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
The IMRIS ORT100 and ORT300 table rotational locking mechanism may experience a failure. The ORT100 rotational locking mechanism can become disengaged or unlocked while in use, which could potentially result in unintended movement of the table due to the older lock design. The ORT300 rotational lock may fail to operate such that it cannot change states between locked and unlocked as a result of actuator failure due to improper adjustment of the actuator or the linkage.
There have been no reports of injury as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Emergo is advising:
- for users with ORT 100 tables: the rotational locking mechanism in all affected ORT 100 tables will be replaced with the most current design;
- for users with ORT 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary.
This action has been closed out on the 06/12/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |