—#104054

Product

Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K001163
Affected lot / code info: 116001, 116012, 116044, EM7-008, 116055, 116064, 116014, 116052, 116023, 116056, 116053, 116047, 116043, 116051, 116070, 116122, 116063, 116020, EM7-003, EM-029, EM7-006, 116024, 116068, 116013, EM3-026, EM3-004, 116046

Why it was recalled

It is possible to load different patients in the record and verify (R&V) system and in the multilead control software (MCS).

Root cause (FDA determination)

Device Design

Action the firm took

Elekta, Inc. sent an "IMPORTANT NOTICE" letter dated May 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter recommends several precautions customers should use until Elekta finds a solution. Customers will be contacted when a solution is found.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: Nationwide Distribution-USA including the state of CT, FL, GA, IA, MN, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA , and WA.

Timeline

Recall initiated: 2011-05-25
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104054. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.