MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy

FDA device recall Z-0115-2016 · posted 2015-10-09 · Terminated

Recall details

Recalling firm

Viewray Incorporated

Reason for recall

ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.

Action taken

ViewRay sent an Customer Advisory Notice dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It is recommended that if you have a patient on the couch and you receive the fault ''The patient table has experienced an unintended movement. This may be due to the patient or operator leaning on the table. Clear the fault and retry. If the problem persists call Service" on the TPDS,first attempt to clear the fault. If it does not clear and requires you to restart the couch software (same switch as restarting the RTCS) you should manually remove the patient from the couch before restarting the system. A software patch to address this issue is planned for early 2016. In the meantime please practice our recommendation of removing the patient from the couch prior to restarting the RTCS. If you have any questions or concerns regarding this issue, please do not hesitate to contact ViewRay Customer Support at support@viewray.com or call the ViewRay Customer Support center at 855-286-8875.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

4 units

Distribution

US Distribution to the states of : CA, MO and WI., and Internationally to Korea.

Date initiated

2015-08-27

Date posted

2015-10-09

Date terminated

2017-06-09

Location

Oakwood Village, OH

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