Reported Oct 6, 2021 · Ongoing
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation…
Elekta Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Inc · 1450 Beale St Ste 205 · Saint Charles, MO · 63303
Is this the product you have?
- Elekta Monaco - Product Usageused to make treatment plans for patients with prescriptions for external beam radiation therapy
- Lot codes and dates
- Software Builds
5.40.005.40.015.40.025.51.10
- UDI GTIN
(01)00858164002190(10) 5.40.00(01)00858164002190(10) 5.40.01(01)00858164002190(10) 5.40.02(01)00858164002268(10) 5.51.10
- Software Builds
- Amount recalled
- 214 units
Where it was sold
Why it was recalled
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
This product could cause temporary or reversible health problems — stop using it.
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