一級召修 Respironics V60 Ventilators

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＊＊＊ 衛署醫器輸字第022114號 ＊＊＊  "磊仕"連續式呼吸器 台灣飛利浦股份有限公司

http://v60.respironics.com/ 

---->各位如果自己院中若有本設備，請先確認是否是名列受影響的清單中，需召修者，請跟當地Philips公司連絡

Respironics California, Inc., V60 Ventilators

Recall Class: Class I
Date Recall Initiated: June 4, 2013
Product: Respironics California, Inc., V60 Ventilators

To find Respironics Material P/N (Philips 12 Digit P/N) and Serial Numbers that are affected by this recall please see: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=118739¹ 

(受影響的清單)

The recalled products were manufactured from March, 2009 through April, 2013 and distributed from November 16, 2009 through March 28, 2013.
Use: The Respironics V60 ventilator provides continuous or intermittent breathing support to pediatric patients weighing 44 pounds or greater to adult patients. This ventilator is used in hospitals or other health care facilities under the direction of qualified medical professionals such as physicians, nurses, and respiratory therapists.
Recalling Firm:Respironics California, Inc.
2271 Cosmos Court
Carlsbad, California 92011-1517
Reason for Recall: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator(因電源電路板上軟體問題，若電源板上零件失效時，可能會造成呼吸器警報聲響失效). This recalled product may cause serious adverse health consequences, including death.
Public Contact: Customers may contact their local Philips Respironics representative at 1- 800- 722-9377 for any questions about this recall.
FDA District: Los Angeles District Office
FDA Comments:On June 3, 2013, Philips Healthcare sent a "MEDICAL DEVICE CORRECTION" letter to all customers who received the V60 Ventilators. The letter described the product, the problem, and the actions to be taken.
Phiilps己放2013/06/03發出通知函給各使用者，內容已有說明本次問題及可採取的因應措施
Customers were informed that the V60 ventilator may continue to be used according to its directions for use, pending the completion of the software update. In addition, customers were instructed to refer to their manual for additional information on warnings.
A Philips Field Service Engineer, Approved Service Provider, or Distributor will be contacting customers to schedule a no-cost update and replacement of the Power Management Board Assembly Software on all V60 ventilators shipped from the manufacturer prior to April 1, 2013.
當地Philips公司會與使用單位連絡並安排受影響需召修設備(2013/04/01後製造)的免費軟體升級
Customers were instructed to contact their local Philips Respironics representative at 1-800-722-9377 for any further information or support concerning this issue.

Class I 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 adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program² either online, by regular mail or by FAX.