| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01255-1 |
| Product Name/Description |
Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)
All PDMs produced from April 2007 through June 2010
Serial Numbers: SA30713XXXXXX to SA31026XXXXXX
ARTG Number: 118982 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Fluid can pass through the seals in the top cover and come into contact with energised contacts in the circuit board. This can result in heat buildup, smoke, and discoloration. This heat buildup could potentially result in thermal injury to a patient or a caregiver. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to inspect the top cover for signs of heat buildup or discolouration. Remove from use if any evidence of damage is observed. GE is advising users to refrain from spraying fluid onto device. A new cover will be installed on all affected devices as a permanent fix when available. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |