Z-0679-2019 Class II Terminated
FDA device recall Z-0679-2019 was initiated by RAYSEARCH LABORATORIES AB on Nov 12, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 17, 2020). Affected quantity: 69.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Nov 12, 2018
- Termination Date
- Apr 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69
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.
Distribution Pattern
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
Code Information
Software version number: 3.5.0.16 , 3.5.1.6 , 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 6.0.0.24 , 6.1.0.26, 6.1.1.2 , 6.2.0.7 , 7.0.0.19 , 8.0.0.61 or 8.0.1.10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0679-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026