Z-1184-2012

Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The...

Name: Z-1184-2012 Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The...
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-02-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-02-07 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of 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... on 2012-02-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1184-2012
Status: Terminated
Initiated: 2012-02-07
Posted: 2012-03-07
Terminated: 2012-08-14
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IXI Block, Beam-Shaping, Radiation Therapy
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 46 active devices
Distribution: 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.
Product codes and lots: ModuLeaf, 110V/60Hz, part number 7334043; ModuLeaf, 220V/60Hz, part number 7334050.

Product code IXI

K030609Class IIModuleafMrc Systems GmbH / cleared 2003-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)