Recalls / —

—#49684

Product

Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K982713

Affected lot / code info

Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)

Why it was recalled

Unexpected Diaphragm movement when manual field size modifications are not saved.

Root cause (FDA determination)

Software design

Action the firm took

Consignees were notified by letter on/about 11/23/2006

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd., Building 300 Suite 300, Norcross, Georgia 30092-3023

Distribution

Distribution pattern

Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .

Timeline

Recall initiated

2006-11-23

Posted by FDA

2007-02-07

Terminated

2008-05-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.