Recall Z-0156-2007 ยท MOQ Battery, Replacement, Rechargeable
Lumiport, LLC
DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.
| Date | Nov 7, 2006 (initiated Sep 28, 2006) |
| Status | Terminated |
| Reason | Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device. |
| Root cause | Other |
| Action | Individual customers were contacted through e-mail and/or telephone beginning 09/28/2006. They were told to stop charging and using their current DermaStyle and to destroy it to prevent accidental usage. New replacements will be mailed to all customers. |
| Quantity | 2480 units |
| Distribution | World wide Distribution-sales by direct mail or internet-USA and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.