Reported Aug 1, 2018 · Terminated
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage:…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system
- Product UsageTo support and aid in positioning a patient during radiation therapy
- Lot codes and dates
- UDI 04056719001698
- Serial numbers
725 of 725 codes
423804238442626030054200942012420134206242068421064210742126421534221742224422924229342301424354249142496425174261542620426904269142731030194209242222423564238242601426494265842743422890300042311425864247103017030224205742058421294215942187422790298202986029914200442113421784218942202422074220942212
- Amount recalled
- 725 devices
Where it was sold
- Nationwide
Why it was recalled
Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.
This product could cause temporary or reversible health problems — stop using it.
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