A flaw in the device's software — logic, interface, or update — triggered the recall. The FDA lists 271 recalls with this root cause since 2025, 26 of them Class I (most serious). Most recent report: Aug 19, 2026.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead…
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss…
Firmware issue potentially leading to loss of geometry movements.
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI…
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.…
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime.…
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected d…
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 follo…
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.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.