Recall Z-2457-2015— RAYSEARCH LABORATORIES AB
Class II · Terminated
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2015-05-27, terminated 2017-09-22. It names one FDA 510(k) clearance: K141860. Product: RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.. Reason: Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-27
- Terminated
- 2017-09-22
- Firm location
- Stockholm, N/A, Sweden
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Reason for recall
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.
Data sourced from openFDA. This site is unofficial and independent of the FDA.