ViewRay System, Radiation Therapy System
FDA device recall Z-1580-2015 · posted 2015-05-05 · Terminated
Recall details
- Recalling firm
- Viewray Incorporated
- Reason for recall
- The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
- Action taken
- On January 15, 2014, ViewRay personnel discussed the investigation of the issue (slice mismatch error) with the customer. The firm advised the customer that until the issue was corrected, to not treat patients in non HFS orientations, or to use the MR acquired from the ViewRay system as the primary plan series for non HFS scans. ViewRay installed software version 3.4.5.28 on January 20 and 21, 2014, in order to prevent this slice mismatch error from occurring in any patient position.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1
- Distribution
- US distribution to MO.
- Date initiated
- 2015-01-15
- Date posted
- 2015-05-05
- Date terminated
- 2015-09-23
- Location
- Oakwood Village, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIEWRAY SYSTEM (K111862) | Viewray, Incorporated | 2012-05-22 |