Recall Z-1444-2009 ยท GEX Powered Laser Surgical Instrument
Sybaritic, Inc
Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. incl
| Date | Sep 3, 2009 (initiated Apr 12, 2008) |
| Status | Terminated |
| Reason | Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments. |
| Root cause | Device Design |
| Action | A "Sybaritic" notification letter dated April 15, 2008 was issued to consignees. The letter described the modifications to the protocols for the NannoLight MP50 and the temporary replacement of 585 Filter for the 560 Filter for Vascular Lesions until further notice. They requested the immediate use of the protocols replacing all other versions. A follow-up letter dated June 3, 2008 was issued to customers. The letter included an attachment " Product Notice Nannolight MP50 585 nm "special" filter from Sybaritic, Inc. The letter described the new 585 nm "bandwidth filter". Also the notific |
| Quantity | 59 |
| Distribution | Worldwide Distribution -- US (states of WA, CA, MN, FL and AR), POLAND, THAILAND, CHILE, CANADA, KOREA, AZERBAIJAN, INDIA, SPAIN, ARGENTINA, RUSSIA, GREECE, PHILIPPINES, POLAND, INDIA, JORDAN, TURKEY, MEXICO, URUGUAY,BELGIUM, LEBANON, BULGARIA and SINGAPORE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082033 | NANNOLIGHT INTENSE PULSED LIGHT SYSTEM Global USA Distribution, LLC, Jul 31, 2008 |