RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment

FDA device recall Z-2457-2015 · posted 2015-08-25 · Terminated

Recall details

Recalling firm

RAYSEARCH LABORATORIES AB

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.

Action taken

On May 27, 2015 RaySearch Laboratories distributed Medical Device Correction notices to their customers via courier service. Within the Medical Device Correction notice, RaySearch Laboratories included a workaround to the problem for their customers. Customers should not use structure templates containing derived ROI definitions with non-uniform contractions. They should avoid using non-uniform contractions. In the case non-uniform contractions must be used, enter switched distances manually and review the result carefully before using it for treatment planning. Lastly, do not use humerus shielding in Automatic Breast Planning. Customers are also expected to complete and return the lower portion of the correction notice via fax to 888-501-7195. **CAPA** Correct the software problem in patch version 4.7.2 of RayStation 4.7, scheduled for market release June 2015.

Root cause

Software design

Status

Terminated

Product code

MUJ

Quantity affected

126 programs

Distribution

Distributed in CO, IL, MI, NC, OH,TN, and WA.

Date initiated

2015-05-27

Date posted

2015-08-25

Date terminated

2017-09-22

Location

Stockholm, Sweden

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