Medical DeviceDec 19, 2018
GE Healthcare PROCARE B20 Patient Monitor, V1 recall — FDA Z-0583-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Recall history in this database
Classification mix: Class II: 236, Class I: 17, Class III: 6.
Medical DeviceDec 19, 2018
GE Healthcare Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting recall — FDA Z-0606-2019
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare B20i Patient Monitor and B20i V2 Patient Monitor recall — FDA Z-0585-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable recall — FDA Z-0586-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare GE LOGIQ E10 Ultrasound System, Model #530000E10 recall — FDA Z-0588-2019
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare PROCARE B40 Patient Monitor, V1 recall — FDA Z-0584-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare Discovery NM/CT 670 Pro, model 5376204-70-54 recall — FDA Z-0608-2019
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare B105/125 Patient Monitor recall — FDA Z-0587-2019
Patient monitors may restart due to network overload caused by network configuration.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 19, 2018
GE Healthcare Discovery NM/CT 670 ES, model 5376204-70-57 recall — FDA Z-0607-2019
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could…
Class IIFDA: CompletedGE Healthcare, LLC
Medical DeviceDec 12, 2018
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 recall — FDA Z-0463-2019
The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate…
Class IFDA: TerminatedGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Dash 5000 Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0521-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Solar 9500 Information Monitoring System is used to monitor physiologic recall — FDA Z-0524-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Solar 8000M Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0523-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Dash 3000 Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0519-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Dash 4000 Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0520-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
GE Healthcare Solar 8000i Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0522-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceNov 28, 2018
GE Healthcare Giraffe Incubator Carestation recall — FDA Z-0480-2019
Potential electric leakage affecting the user.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 28, 2018
GE Healthcare Panda Freestanding Warmer recall — FDA Z-0483-2019
Potential electric leakage affecting the user.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 28, 2018
GE Healthcare Giraffe OmniBed Carestation recall — FDA Z-0479-2019
Potential electric leakage affecting the user.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 28, 2018
GE Healthcare Giraffe Warmer. Device sold under the following product names: Giraffe Warmer recall — FDA Z-0481-2019
Potential electric leakage affecting the user.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 28, 2018
GE Healthcare Panda iRes Infant Radiant Warmer recall — FDA Z-0482-2019
Potential electric leakage affecting the user.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
GE Healthcare Aisys Anesthesia System recall — FDA Z-0411-2019
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
GE Healthcare Aisys CS2 Anesthesia System recall — FDA Z-0412-2019
Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceNov 21, 2018
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL recall — FDA Z-0370-2019
A detector can detach and fall.
Class IFDA: TerminatedGE Healthcare, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies GE Healthcare, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.