Linvatec 電動骨鑽cable 及Handpiece 一級回收

(http://bme.freebbs.tw 醫學工程論壇 同步發表)
ConMed Linvatec - Power Pro Handpieces
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181784.htm

ConMed Linvatec - Universal Cables
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm181786.htm

Recall Class:Class I

Date RecallInitiated:July 31, 2009

Product:Universal Cables, MC5057-->我們醫院用的是MC5056，但因為財產沒有登記細項，必需去清查一下或是問一下台灣代理商
The lot numbers affected by this recall are included in this attachment. The cables have date codes etched on one end of the cable and range from JAN-01 to NOV-06 representing the month and the year.Attachment: Universal Cable Serial Numbers, Excel (158kb)These cables were manufactured from January 3, 2001 through November 30, 2006 and distributed from January 24, 2001 through February 27, 2009.See related Linvatec Class I recall

Use:The cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source.

Recalling Firm:Linvatec Corporation doing business as (dba) ConMed Linvatec11311 Concept BoulevardLargo, Florida 33773-4908

Reason for Recall:The cable may cause the electric handpiece to self-activate.

Public Contact:ConMed Linvatec Customer Service1-800-237-0169Monday-Friday, 7 AM to 7 PM Eastern TimeFor more information, see Useful Links below.

FDA District:Florida

FDA Comments:The company sent a letter to their customers with the following instructions:
Inspect the cords for signs of excessive wear or damage.
Stop using the cable if damaged or worn and replace it immediately.
Stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs. Return the cable and handpiece to the company for evaluation.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.Useful Links:
Firm Press Release http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm
MedWatch: The FDA Safety Information and Adverse Event Reporting Program