Devices

Device Recall AlignRT Plus private labelOSMS Varian

Model / Serial
Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
Product Description
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
Manufacturer
Vision RT Ltd
1 Event
- Recall of Device Recall AlignRT Plus private labelOSMS Varian

Manufacturer

Vision RT Ltd

Manufacturer Address
Vision RT Ltd, Dove House, Arcadia Avenue, London United Kingdom
Manufacturer Parent Company (2017)
William Demants Og Hustru Ida Emilies (Millas) Fond - Kaldet Oticon-Fonden
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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