Z-2091-2019 Class II Ongoing
FDA device recall Z-2091-2019 was initiated by Elekta Inc on July 3, 2019 and is designated Class II. Reason for recall: When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectl… The recall status is ongoing. Affected quantity: 1396 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- July 3, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1396 units
Product Description
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Reason for Recall
When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.
Distribution Pattern
worldwide
Code Information
all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11