Sonesta S2 Chair Recalled for Incorrect Patient Weight Information in Manual
Sonesta Medical Ab is recalling 28 Sonesta S2 chairs because the user manual contains incorrect maximum patient weight information.
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, but the hazard is limited to incorrect information in the manual (documentation issue) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation error.
Plain-English summary
Sonesta Medical Ab is recalling 28 units of the Sonesta S2 chair, including article numbers 525-S2-110V and 525-S2-220V. The recall was initiated because the user and service manual for the device contains incorrect information regarding the maximum patient weight.
The affected devices were distributed worldwide, including in the United States (Massachusetts) and in Canada, the Netherlands, Dubai, Taiwan, Lebanon, and Italy. The specific serial codes for the recalled units are listed in the agency's recall record.
Consumers and healthcare facilities should stop using the affected manuals and contact Sonesta Medical Ab for further instructions or replacement documentation. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
- Manufacturer
- Sonesta Medical Ab
- Category
- Medical Device — Patient Chair
- Affected units
- 28
Distribution
Distributed in 1 state:
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