Z-1894-2017Class II

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

Name: Z-1894-2017 Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V
Creator: Sonesta Medical Ab
Published: 2017-03-08
License: https://open.fda.gov/license/

Sonesta Medical AB / initiated 2017-03-08 / Terminated / root cause: labeling and UDI

FDA source

Sonesta Medical Ab began a recall of Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V on 2017-03-08. FDA classified it as Class II and gives the reason as "The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1894-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-08
Posted: 2017-04-28
Terminated: 2019-08-20
Recalling firm: Sonesta Medical AB
Product: Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V
Product code: MMZ Table, Cystometric, Electric
Reason for recall: The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 28 devices
Distribution: Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1894-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1894-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-04-28

Product code MMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)