Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended
FDA device recall Z-0796-2012 · posted 2012-01-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Action taken
- Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 327 Active Devices - all models
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-12-01
- Date posted
- 2012-01-17
- Date terminated
- 2013-12-02
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEVATRON, M 2 CLASS (K882729) | Siemens Medical Laboratories, Inc. | 1988-09-19 |