Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reported: December 7, 2016 Initiated: November 3, 2016 #Z-0660-2017
Product Description
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Incorrect Dose when using the reset function.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 671
- Distribution
- AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Recalled by Elekta, Inc.. Units affected: 671.
Why was this product recalled? ▼
Incorrect Dose when using the reset function.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0660-2017.
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