Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to
FDA device recall Z-1444-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Sybaritic, Inc
- Reason for recall
- 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.
- Action taken
- 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 notification advised consignees to discontinue the use of the old 585 filter and to use 560nm filter until they receive the new 585 nm bandwidth filter. Please direct any questions to your Account Manager or to Sybaritic, Inc. by calling 1-800-445-8418 or 1-952-888-8282.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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,
- Date initiated
- 2008-04-12
- Date posted
- 2009-09-03
- Date terminated
- 2012-07-05
- Location
- Bloomington, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NANNOLIGHT INTENSE PULSED LIGHT SYSTEM (K082033) | Global USA Distribution, LLC | 2008-07-31 |