Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use
FDA device recall Z-1184-2012 · posted 2012-03-07 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IXI
- Quantity affected
- 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, Japa
- Date initiated
- 2012-02-07
- Date posted
- 2012-03-07
- Date terminated
- 2012-08-14
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULEAF (K030609) | Mrc Systems GmbH | 2003-03-17 |