Device Recall Light Source, Endoscopic, Xenon Arc 의 리콜

Recall

63009

Class 2

Z-2455-2012

2011-05-20

2012-09-25

Terminated

United States

2012-09-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112254

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.

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 Service (800-237-0169) to receive SR Number Advance Exchange affected product only. Once Customer Service authorizes the SR Number your Advance Exchange Light Source will be shipped to your facility; 3) Once replacement unit is received, utilize the packaging material to return the recalled Light Source to ConMed Linvatec using the enclosed FedEx Airway Bill. Mail or FAX copy of Reply Form to ConMed Linvatec; 4) Complete and return a copy of the Reply Form. For questions contact your local ConMed Linvatec office or email Custseryl@linvatec.com, Customer Service at 800-237-0169 or fax to 727-319-5701.