HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Reported: September 7, 2016 Initiated: August 18, 2016 #Z-2691-2016
Product Description
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Reason for Recall
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 13
- Distribution
- Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.. Recalled by Elekta, Inc.. Units affected: 13.
Why was this product recalled? ▼
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2016. Severity: Moderate. Recall number: Z-2691-2016.
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