Recall Z-1423-2009 ยท ISA Massager, Therapeutic, Electric
Sybaritic, Inc
Sybaritic, Inc., SlimLine Health Environment Capsule, a dry heat body chamber with facial and body chamber LED panels.
| Date | Jun 23, 2009 (initiated Jun 18, 2008) |
| Status | Terminated |
| Reason | Misbranded and sale without pre-market notification. |
| Root cause | PMA |
| Action | Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA. |
| Quantity | 1 |
| Distribution | UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.