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Terminated

Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V

FDA Recall Z-1894-2017 · Posted None

Recalling FirmSonesta Medical Ab
Recall StatusTerminated
Product CodeMMZ
Date Initiated2017-03-08
Date Terminated2019-08-20
Product Quantity28 devices

Reason for Recall

The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

Firm Action

Sonesta notified customers (distributors) on March 8, 2017, of the faulty labeling. Corrected labeling was sent to customers, they were requested to apply the new labels and confirm that the correction was implemented. For further information regarding this recall, please call (512) 327-9997.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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