| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01027-1 |
| Product Name/Description |
B20, B30, B40 Patient Monitors (used for ECG monitoring)
Serial Numbers: B20 - SGF11030001WA to SGF13176741WA (software version 1)
B30 - SF309380033WA to SF313177120WA (software version 2)
B40 - SG211210001WA to SG213172146WA (software version 1)
B40 - SJF13010005WA to SJF13180144WA (software version 2)
ARTG Number: 92726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The additional 0.5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values. The ST-elevation measurement can be under estimated in this situation and treatment of the patient can be delayed.Please note that there is no issue when the monitor starts with impedance respiration set in the OFF position. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is providing users with work around instructions to follow until a software correction is available. |
| Contact Information |
1800 659 465 - GE National Call Centre |