Medical Device Recall: Z-0036-2012

FDA Recalls dataset · Firm: Accuray Incorporated · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-09-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2012.

Recall Res Number
Z-0036-2012
Recalling Firm / Manufacturer
Accuray Incorporated
FEI Number
1000123585
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-09-12
Date Posted
2011-10-11
Date Terminated
2012-02-27
Product Code
IYE
Event Number
59937
Product Quantity
236 total devices
Product Description CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Reason for Recall A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly.
Action Details Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.
Distribution Pattern Worldwide Distribution
Code Information / Serial Numbers Model numbers 026430 and 028186. All units

Related Establishments / Registrations

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