Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:16868
Brand Name:GE CareScape Patient Monitor, Multi-Parameter
Model:Models: B850, B650, B450
Affected:
Software version:Version 2 software
Recalling Organisation:GE Healthcare Limited
Level 7, Vero Centre
48 Shortland St
Auckland 1010
Contact Information:0800 659 465
Manufacturer:GE Healthcare Finland Oy
Issue:When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
This issue happens after the following sequence of events:
1. The PDM is connected to a Transport Pro or Solar monitor.
2. At least one arrhythmia or ST-change snapshot is saved in the PDM.
3. The PDM is then connected to the CARESCAPE Bx50 monitor.
4. More than 740 arrhythmia or ST-change snapshots are then saved in the PDM.
5. The PDM is then disconnected and connected back to the CARESCAPE Bx50 monitor.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:24/6/2014
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