Recalls / —

—#107631

Product

Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.

FDA product code

IXI — Block, Beam-Shaping, Radiation Therapy

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K030609

Affected lot / code info

ModuLeaf, 110V/60Hz, part number 7334043; ModuLeaf, 220V/60Hz, part number 7334050.

Why it was recalled

This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, SIEMENS, issued a "Customer Information" letter to its customers. The letter described the product, problem and actions to be taken. Siemens developed a new steel knob that complies with the latest standards; Siemens checked all ModuLeaf mMLC trolleys and if necessary refitted with the safety label and also arranged for an inspection and modification of the customers system- a Release of the safety update UI TH 026/11/S to distribute and hardware update commenced on February 7, 2007 by certified mail. If you have any questions, contact the Regulatory Specialist II at 925-602-8175.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: CO, IA, KY, NJ, OH and TX; and countries of: Algeria, Austria, Belgium, Brazil, China, Egypt, France, Germany, Hungary, India, Italy, Japan, Kuwait, Malaysia, Mexico, P.R., Russian Fed., Saudi Arabia, South Africa, Spain, Turkey, and United Kingdom.

Timeline

Recall initiated

2012-02-07

Posted by FDA

2012-03-07

Terminated

2012-08-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #107631. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.