FDA Medical Device Recalls (openFDA)
Sonesta Medical Ab: Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V
- Recall number
- Z-1894-2017
- Recalling firm
- Sonesta Medical Ab
- Product
- Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V
- Status
- Terminated
- Initiated
- 2017-03-08
- Posted
- not on file
- Terminated
- 2019-08-20
- Reason
- The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
- 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
- 28 devices
- Distribution
- Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MMZ
- Firm FEI
- 3010496070
- Firm city
- Bromma
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28