Type of Product |
Medical Device |
TGA Recall Reference |
RC-2021-RN-01345-1 |
Product Name/Description |
CARESCAPE Patient Data Module (PDM)
Module Identifier: CARESCAPE PDM (New) Product Code: SA3 or SPX Model Number: 2042084-001 GTIN: 00840682104784
CARESCAPE PDM (Goldseal) Product Code: SA3 or SPX Model Number: 2094504-001 GTIN: 00840682110440
Multiple Software Media and FRU part numbers
ARTG 118982 (GE Medical Systems Australia Pty Ltd - Patient monitor module, multifunction) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
11/06/2021 |
Responsible Entity |
|
Reason/Issue |
If the CARESCAPE PDM with Masimo SET technology has not been powered down completely in more than 2 years, it can display a frozen SpO2 saturation value that is inaccurate and no longer changes to reflect the patient’s clinical condition. If this situation were to occur, it could result in missed SpO2 alarms and delayed diagnosis and treatment of hypoxia or hyperoxia. |
Recall Action |
Product Defect Correction |
Recall Action Instructions |
GE Healthcare will correct all affected products via a software update at no cost. A GE Healthcare representative will contact facilities to arrange for the correction.
In the interim, users can continue to use the CARESCAPE PDM with Masimo SET technology by completing the power down instructions below annually:
1. If the PDM is on a patient, provide alternate monitoring if needed, during the power down process. 2. Disconnect the PDM from the display device by removing the PDM from the mounting dock or by disconnecting the communication cable from the back of the PDM. 3. Open the battery door compartment and remove the battery (if present), for approximately 10 seconds. 4. Reinsert the battery and reconnect the PDM to the display device.
Note: This issue can only occur if the PDM has not been powered down for more than 2 years. Completing this process once a year, prevents this safety issue from occurring until the software correction is installed.
This action has been closed out on 22/02/2024 |
Contact Information |
1800 659 465 - GE Healthcare Service |