HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with
FDA device recall Z-2691-2016 · posted 2016-08-30 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- 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.
- Action taken
- Elekta sent an Important User Notice 618-03-303-025 to affected customers on 8/18/2016. The notice identified the affected product, problem, clinical impact, solution and actions to be taken. The Notice reminds users that the Interlock Check is not possible during 3D Workflow as iGUIDE is not in use. The notice reminds users that if iGUIDE is not being used - (A) Ensure the HexaPOD is at its pre-defined 3D position before treatment, and (B) Ensure the External Inhibit LED at the EnableSwitch Board is off. For questions contact your local Elekta office.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity 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.
- Date initiated
- 2016-08-18
- Date posted
- 2016-08-30
- Date terminated
- 2017-05-23
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IGUIDE SYSTEM (K072079) | Medical Intelligence Medizintechnik-GmbH-An Elekta | 2007-08-14 |