Reported Dec 18, 2019 · Ongoing
Monaco Radiation Treatment Planning System (RTP) System
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?
- Monaco Radiation Treatment Planning System (RTP) System
- Lot codes and dates
- Software Builds
5.40.005.50.00 and 5.51.00
- UDI GTIN
(01)00858164002190(10) 5.40.00(01)00858164002244(10) 5.50.00and (01)00858164002268(10) 5.51.00
- Software Builds
- Amount recalled
- 76 (7 US, 69 OUS)
Where it was sold
Why it was recalled
Monaco is using the incorrect energy when optimizing and calculating dose.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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