Recalls / —

—#109148

Product

MLCi/MCLi2. Radiation therapy.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K082122

Affected lot / code info

MRT 2424/MRT 14401

Why it was recalled

The Y2 diaphragm block was found loose.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to carry out the recommended weekly physics check of the X-ray and light field size calibration. If an error is found, customers are instructed to contact their local Elekta service engineer.

Recalling firm

Firm

Elekta, Inc.

Address

4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern

Nationwide Distribution including Puerto Rico.

Timeline

Recall initiated

2012-04-19

Posted by FDA

2012-05-23

Terminated

2014-10-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #109148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.