Elekta Recalls HexaPOD evo RT Couch Top for Positioning Errors
Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect patient positioning during radiation therapy, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Elekta, Inc. is recalling 725 units of the HexaPOD evo RT Couch Top, also known as the HexaPOD evo Module. This component is part of the HexaPOD evo RT system and is used to support and aid in positioning a patient during radiation therapy. The devices were distributed nationwide in the United States and to numerous countries worldwide, including Canada, Australia, and various nations in Europe, Asia, and the Americas.
The recall was initiated because the HexaPOD evo Module may remain in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments after the completion of a 6D workflow. This condition can result in incorrect patient positioning during radiation therapy. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
Healthcare facilities and users of the HexaPOD evo RT system should stop using the affected devices and contact Elekta, Inc. for instructions on how to proceed. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 725
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 04056719001698. Serial numbers: 42380
- 42384
- 42626
- 03005
- 42009
- 42012
- 42013
- 42062
- 42068
- 42106
- 42107
- 42126
- 42153
- 42217
- 42224
- 42292
- 42293
- 42301
- 42435
- 42491
Distribution
Distributed nationwide across the United States.
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