Recall Z-1894-2017— Sonesta Medical Ab
Class II · Terminated
Class II FDA medical device recall by Sonesta Medical Ab, initiated 2017-03-08, terminated 2019-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V. Reason: The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight..
- Recalling firm
- Sonesta Medical Ab
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-08
- Terminated
- 2019-08-20
- Firm location
- Bromma, Sweden
Product description
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
Reason for recall
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Data sourced from openFDA. This site is unofficial and independent of the FDA.