| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01072-1 |
| Product Name/Description |
OEC 9800, OEC UroView 2800, OEC MiniView 6800, OEC FlexiView 8800 (mobile flouroscopic x-ray diagnostic system)
Systems supplied in Australia:
System: OEC 9800
Serial Number: 86-1220
Sysem: OEC 6800
Serial Number: 89-2550
ARTG Number: 132698 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
There are potential safety issues due to part replacements associated with certain components as follows:
Safety Issue #1: The workstation cover may be able to be removed without the use of a tool. If the workstation front cover is removed, the user could be exposed to high voltage resulting in an electric shock.
Safety Issue #2: Surge Suppressor Board may have been replaced with an earlier revision. If the surge suppressor board is subjected to high voltage surges, damage to surge suppressor board components may occur and prevent the system from booting.
Safety Issue #3: Solid state drive may have been replaced with a magnetic hard disk drive. The magnetic hard disk drive is more susceptible to data corruption that may prevent the system from booting.
Safety Issue #4: Workstation power cable may have been replaced with an earlier revision which contains an unnecessary connection that could be subject to a potential connection failure, and prevent the system from booting. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A GE Healthcare Field Engineer will contact customers to coordinate an inspection of the affected part/s, replacement of the affected part/s if necessary, and will ensure that systems meet the specifications. Work around instructions have been provided in the interim for each of the safety issues identified above. This action has been closed-out on 07/06/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |