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Recall2026-06-22Health CanadaRA-82239CyberKnife Treatment Delivery System
CyberKnife Treatment Delivery System — Type II recall: performance malfunction can occur when the collimator housing is moved over the Xchange table, causing the robot to lock up and halt operation. Affects 4 system units (lots C0417, C0545, C0573, C0351). Facilities told to clear the treatment area, not move the robot via the in-room pendant, and contact Accuray service. No injuries reported.
cause not establishedRA-82239Read the record ↗Recall2026-02-19Health CanadaRA-81627Monarch Platform (Model MON-000006)
Monarch Platform (Model MON-000006) — Type II recall: rare software glitch where the app may restart during procedure setup, resetting patient-side state to patient-left if it had been set to patient-right, risking unintended robotic-arm movement toward the wrong anatomical side. No injuries reported; facilities told to contact the manufacturer.
cause not establishedRA-81627Read the record ↗Recall2026-02-19Health CanadaRA-81626Hugo RAS Bipolar Maryland Forceps and Hugo RAS Bipolar Fenestrated Grasper
Hugo RAS Bipolar Maryland Forceps and Hugo RAS Bipolar Fenestrated Grasper — Voluntary safety notice: increased likelihood of drive-cable pulley-assembly component failure due to manufacturing variations, which can make instrument jaw control incorrect/uncontrolled and may detach a white plastic pulley component inside the patient's body. The Hugo RAS system automatically detects and halts control of the affected instrument when this occurs. No injuries reported.
cause not establishedRA-81626Read the record ↗Recall2025-12-19Health CanadaRA-81382Mazor X System
Mazor X System — Type II recall for the Mazor X surgical robotic guidance platform (6 affected serial numbers) tied to software v5.2, which resolved 111 anomalies from prior versions; 7 of those are evaluated as having observed or potential harm greater than negligible. No injuries reported; facilities told to contact the manufacturer.
cause not establishedRA-81382Read the record ↗Recall2024-11-06Health CanadaRA-76453Kinova Jaco assistive robotic arm
Kinova Jaco assistive robotic arm — Type II recall (initiated 2024-08-12): damaged Jaco robotic arms could pose a fire risk if used with wheelchairs having electrical leakage. Affects all production lots across six model variants. No injuries reported; affected users advised to contact Kinova for guidance.
cause not establishedRA-76453Read the record ↗Recall2023-09-15Health CanadaRA-74289Hugo Robotic-Assisted Surgery (RAS) Tower, 120v
Hugo Robotic-Assisted Surgery (RAS) Tower, 120v — Type II recall (initiated 2023-08-24, lot/serial C22AKC0070): calibration failures prevented the robotic arm from entering teleoperation mode even after recalibration attempts, causing procedural delays. No injuries reported; facilities told to contact Covidien.
cause not establishedRA-74289Read the record ↗Recall2022-01-01Health CanadaRA-63783Mazor X Robotic Guidance System
Mazor X Robotic Guidance System — Type II recall (initiated 2021-12-16) for software v5.0.1 issues: potential unintended movement of the robotic arm into restricted work-volume areas (emergency stop remained functional), and possible undetected loss of communication between the console computer and the surgical arm causing unexpected arm positioning. One customer complaint of unintended arm movement; zero complaints on the communication-loss issue.
cause not establishedRA-63783Read the record ↗Recall2020-12-21Health CanadaRA-74597iRobot Clean Base for Roomba i7+ Robot Vacuum
iRobot Clean Base for Roomba i7+ Robot Vacuum — Automatic dirt-disposal dock for certain Roomba i7+ models poses an electrical hazard: significant liquid ingestion by the vacuum can disperse onto the dock's internal circuit board and cause a short circuit. 11,971 units sold in Canada Jul 2018-Mar 2020. No incidents or injuries reported in Canada as of 2020-12-08. Free repair (fused cord) or replacement offered.
cause not establishedRA-74597Read the record ↗Recall2019-11-26Health CanadaRA-71710Cyberknife VSI Robotic Radiosurgery System
Cyberknife VSI Robotic Radiosurgery System — Type II recall (Model 033000-010, Lot C0238) for potential unintended drop of a secondary collimator housing, affecting both Cyberknife M6 and VSI treatment delivery systems. No injuries or deaths reported in connection with the issue.
cause not establishedRA-71710Read the record ↗