Events

Recall of Device Recall Sonesta S2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonesta Medical Ab.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77075
  • Event Risk Class
    Class 2
  • Event Number
    Z-1894-2017
  • Event Initiated Date
    2017-03-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154929
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, cystometric, electric - Product Code MMZ
  • Reason
    The user / service manual for the sonesta s2 chair contain wrong information concerning the maximum patient weight.
  • 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.

Device

Device Recall Sonesta S2
  • Model / Serial
    12-00001-110V 12-00011-110V 23-00002-220V (Demo Product) 12-00002-110V 12-00012-110V 23-00001-220V 12-00003-110V 12-00013-110V 23-00003-220V 12-00004- 110V 12-00014-110V 23-00004-220V 12-00005-110V 12-00015-110V 23-00005-220V 12-00006-110V 12-20001-110V 23-00006-220V 12-00007-110V 12-20002-110V 23-00009-220V 12-00008-110V 12-20003-110V 23-00020-220V 12-00009-110V 12-20004 -110V 23-20001-220V 12-00010-110V 23-20002-220V
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
  • Product Description
    Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
  • Manufacturer
    Sonesta Medical Ab

Manufacturer

Sonesta Medical Ab
  • Manufacturer Address
    Sonesta Medical Ab, Adolfsbergsvagen 31, Bromma Sweden
  • Manufacturer Parent Company (2017)
    Addvise Group Ab
  • Source
    USFDA