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Terminated

Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process.

FDA Recall Z-1066-2012 · Posted 2012-02-21

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-01-26
Date Terminated2012-04-17
Product Quantity96 units

Reason for Recall

If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.

Firm Action

ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 770-670-2548

Root Cause

Software design

Distribution Pattern

Nationwide Distribution including AR, AZ, CA, CT, FL, GA, ID, IL, LA MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI, and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100115XVI R4.5Elekta , Ltd. · 2010-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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