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 Recall Z-1184-2012 · Posted 2012-03-07
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIXI
Date Initiated2012-02-07
Date Terminated2012-08-14
Product Quantity46 active devices
Reason for Recall
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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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