| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00873-1 |
| Product Name/Description |
CareScape Patient Data Module (PDM) with software v2.6
(used with CareScape Monitors B850, B650 and B450 with v2.0.7 or earlier software)
ARTG Number 118982 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare observed during a pre-installation checkout procedure that an impedance respiration APNEA alarm could not be produced with PDM v2.6 and CareScape B850 v 2.0.7 host monitor software. The PDM v2.6 has been limited to a small number of customer sites. The issue was identified in the biomed shop during check out. To date, no actual reported patient incidents of a missed APNEA alarm with PDM v.2.6 have been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare will correct all affected products at no cost to users. A GE Healthcare representative will contact each affected site to arrange for the correction to take place.
This action has been closed out on 12/10/2018 |
| Contact Information |
1800 659 465 - GE National Call Centre |