Recall Z-1894-2017 ยท MMZ Table, Cystometric, Electric
Sonesta Medical Ab
Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V
| Date | Mar 8, 2017 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.