FDA Device Recall Z-0014-2012: Elekta, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2012.

Recall Res Number

Z-0014-2012

Recalling Firm / Manufacturer

Elekta, Inc.

FEI Number

1037831

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-05-25

Date Posted

N/A

Date Terminated

2014-01-14

Product Code

MUJ

Event Number

59949

Product Quantity

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

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

Action Details 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.

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.

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0014-2012

Recall Parameters & Description

Related Establishments / Registrations

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