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| Issued: 18 Jun 2008 at 14:00 |
Ref: MDA/2008/042
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Immediate action |
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Action |
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Update |
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Information request |
| Device: FocalSim radiotherapy treatment planning software manufactured by Computerized Medical Systems Inc. FocalSim software versions 4.3.1 to 4.34.02 inclusive. |
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| Problem: Potential for miscalculation and incorrect display of patient doses leading to over-exposure and/or unnecessary exposure(s) to radiation. |
>Page 2 |
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| Action by: All involved in the use of the FocalSim planning software, including medical physicists, planning radiographers and dosimetrists. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 30 June 2008
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Deadline (action complete): 09 July 2008
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MDA/2008/042 - FocalSim radiotherapy treatment planning software manufactured by Computerized Medical Systems Inc. FocalSim software versions 4.3.1 to 4.34.02 inclusive 
