[Recalled] Monaco Product Usage: Planning of radiation therapy — Incorrect patient shift directions when the Setup reference dialog is printed o… | FDA 2012-06-21
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Monaco Product Usage: Planning of radiation therapy |
|---|---|
| Brand / manufacturer | Elekta, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2007-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Elekta, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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