Recall Z-2455-2012 ยท GCT Light Source, Endoscope, Xenon Arc
Linvatec Corp. dba ConMed Linvatec
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
| Date | Sep 25, 2012 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures. |
| Root cause | Nonconforming Material/Component |
| Action | Linvatec Corporation sent an "URGENT Medical Device Recall Notification letter dated May 20, 2011 to its customers via FedEx service. Firm advised their suppliers of the Light Sources potentially has unapproved components and does not meet the finished product requirement. The distributors and end user level are advised if any affected product is in their possession can be used until returned for advance exchange. The customers were instructed to: 1) locate the identified product by serial number at your facility and complete the Reply Form attached; 2) Contact ConMed Linvatec Customer Servic |
| Quantity | 1 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE Conmed Linvatec, Aug 20, 2007 |