Elekta Recalls HexaPOD evo RT Couchtop Units Due to Loose Screw Risk
Elekta is recalling 266 HexaPOD evo RT Couchtop units because screws may become loose if not properly tightened with a torque wrench.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical component (screws) that may loosen, which is a potential safety risk but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Elekta, Inc. is recalling 266 units of the HexaPOD evo RT Couchtop. This medical device is used to support and aid in positioning a patient during radiation therapy.
The recall was initiated because if screws are not properly tightened with a torque wrench, they may become loose over time. The affected units were distributed worldwide, including in the United States and numerous international countries.
Healthcare facilities should contact Elekta for instructions on how to address the potential loosening of screws on the affected serial numbers.
The recalled product
- Product
- HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
- Manufacturer
- Elekta, Inc.
- Affected units
- 266
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)
- Serial Numbers 42188
- 42246
- 42106
- 42153
- 42107
- 42068
- 42012
- 42013
- 42062
- 42009
- 42224
- 42126
- 3005
- 42222
- 3019
- 3000
- 42058
- 42059
- 42057
- 42187
Distribution
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