Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15582 |
| Brand Name: | GE Carescape Patient Monitor B650 |
| Model: | Model: B650 |
| Affected: | S/W versions 1.1.12 and earlier |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Healthcare Finland Oy |
| Brand Name: | GE Carescape Patient Monitor B850 |
| Model: | Model: B850 |
| Affected: | S/W version 1.0.12 and earlier |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Medical Systems Information Technologies Inc |
| Issue: | The manufacturer has determined that selected software versions of B650 and B850 patient monitors have a number of safety related issues including: 1. Non-invasive blood pressure (NIBP) auto-cycling will not start 2. NIBP auto-cycling stops when selecting Audio & Display off 3. NIBP auto-cycling stops when loading data and measuirng NIBP at the same time 4. Lost NIBP measurements 5. NIBP limit values for infants change when loading a new patient data from a TRAM module 6. Wrong ECG bandwith in E-PSM(P) or E-(P)RE(S)TN modules 7. Changing the primary ECG lead selection in the CIC Pro Central Station will not change the primary measurement lead in PDM or TRAM measurement modules 8. A temp hidden alarm message will not re-activate if a different alarm is acknowledged at iCentral 9. Missing audible alarms from remote monitors after broken network connection 10. Missing ECG waveforms on iCentral. 11. iCentral does not notice a monitor exiting the Standby mode + 14 other issues |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 6/11/2013 |
