Enforcement Report - Week of November 7, 2012
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Product Detail
| Product Description | MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images. |
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| Recall Number | Z-0169-2013 |
| Classification | Class II |
| Code Info | Version 2.00 to 2.41 |
| Product Distributed Qty | 300 |
| Reason For Recall | A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. |
Event Detail
| Event Id | 63335 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Elekta, Inc. |
| City | Norcross |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-18 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and country of Canada. |
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