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CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Roboti...

FDA Device Recall #Z-0865-2017 — Class II — December 6, 2016

Recall Summary

Recall Number Z-0865-2017
Classification Class II — Moderate risk
Date Initiated December 6, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Accuray Incorporated
Location Sunnyvale, CA
Product Type Devices
Quantity 115 affected devices.

Product Description

CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Reason for Recall

Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robotic Radiosurgery System.

Distribution Pattern

Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,

Lot / Code Information

models: G3, G4, VSI. Serial numbers: C0023 C0030 C0045 C0046 C0047 C0006 C0012 C0040 C0048 C0049 C0013 C0011 C0052 C0055 C0022 C0053 C0042 C0057 C0017 C0059 C0056 C0060 C0062 C0061 C0067 C0068 C0070 C0041 C0063 C0065 C0074 C0071 C0079 C0078 C0080 C0064 C0090 C0024 C0087 C0091 C0095 C0094 C0092 C0093 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0089 C0108 C0107 C0105 C0112 C0114 C0118 C0119 C0113 C0123 C0126 C0124 C0121 C0132 C0130 C0131 C0125 C0133 C0135 C0117 C0134 C0038 C0136 C0137 C0127 C0143 C0144 C0014 C0138 C0146 C0140 C0145 C0150 C0033 C0151 C0152 C0147 C0149 C0148 C0158 C0155 C0159 C0007 C0163 C0157 C0165 C0008 C0162 C0085 C0161 C0086 C0073 C0115 C0076 C0153 C0077 C0111 C0066 C0027 C0075 C0084 C0096 C0154.

Other Recalls from Accuray Incorporated

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Z-1272-2021 Class II CyberKnife Treatment Delivery System - Product ... Feb 26, 2021
Z-0784-2021 Class II TomoTherapy Treatment System - Product Usage: u... Dec 10, 2020
Z-0785-2021 Class II TomoTherapy Treatment Delivery System with iDMS... Dec 10, 2020

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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