Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | Monaco RTP System. Radiation treatment planning. |
|---|---|
| Recall Number | Z-0841-2013 |
| Classification | Class II |
| Code Info | Versions 3.20.00 and 3.20.01 |
| Product Distributed Qty | 13 |
| Reason For Recall | The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle. |
Event Detail
| Event Id | 64328 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Elekta, Inc. |
| City | Atlanta |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI. |
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