| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01234-1 |
| Product Name/Description |
Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)
Product Codes: SA3, SG5
All monitors produced from April 2007 to December 2012.
Serial Numbers: SA030713XXXXXX to SA31252XXXXXX and SG050713XXXXXX to SG51252XXXXXX
ARTG Number: 118982 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
26/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The spring inside the mounting latch can become dislodged causing the PDM not to latch properly resulting in an unexpected loss of patient monitoring function. This may also result in the PDM falling onto a patient or caregiver. Warning messages are displayed indicating patient parameters which have been disconnected and also, a three short burst alarm is issued and repeated if acknowledged. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to refrain from mounting the monitor above a patient or caregiver and refrain from mounting the monitor at a downward facing angle. GE Healthcare will be installing a new latch on all units once available. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |