RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Reported: January 2, 2019 Initiated: November 12, 2018 #Z-0679-2019
Product Description
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A
Reason for Recall
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Details
- Recalling Firm
- RAYSEARCH LABORATORIES AB
- Units Affected
- 69
- Distribution
- AZ CA CO CT DE FL GA HI ID IL LA MA MD ME MI MO MS NC NJ NY OH OR PA RI TN TX VA VT WA WI
- Location
- Stockholm
Frequently Asked Questions
What product was recalled? ▼
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. Recalled by RAYSEARCH LABORATORIES AB. Units affected: 69.
Why was this product recalled? ▼
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0679-2019.
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