A flaw in the device's software — logic, interface, or update — triggered the recall. The FDA lists 262 recalls with this root cause since 2025, 26 of them Class I (most serious). Most recent report: Jul 8, 2026.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console.…
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console.…
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g.…
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock…
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without gene…
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without gene…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.