The Recall Desk
ModerateFDA (Devices)·Z-1894-2017·Announced 2017-05-10

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.

What this means for you

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
Affected units
28

Distribution

Distributed in 1 state:

Same manufacturer · Sonesta Medical Ab

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