Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17251 |
| Brand Name: | GE Carescape Bx50 Patient Monitor |
| Model: | Models B850, B650, B450 |
| Affected: | |
| Software version: | PDM software version V2.2 or lower |
| 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: | If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a "Patient Discharge" or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly. The ECG heart rate (HR) parameter data, the ECG waveform analysis and other ECG parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. As a result of the abnormal analysis of data, the alarms for serious conditions may not be triggered appropriately. The issue potentially affects heart rate, ECG ST segment analysis, 12 lead ECG analysis; ECG, SPO2, respiration and invasive blood pressure waveforms both locally and at CIC; and data displayed at CIC may show data drop out. Neither bedside nor CIC data can reliably represent the parameters being measured. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/9/2014 |
