Class 2 Device Recall Espirit Ventilator

• Date Initiated by Firm: June 01, 2001
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 12, 2004
• Recall Number: Z-0903-04
• Recall Event ID: 28803
• 510(K)Number: K981072
• Product Classification: Ventilator, Continuous, Facility Use - Product Code CBK
• Product: Espirit Ventilator, Model V1000; ; Continuous Ventilator with Respiratory Mechanics
• Code Information: All Codes.
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92009-1517
• For Additional Information Contact: Anil Bhalani; 760-703-9207
• Manufacturer Reason for Recall: Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
• FDA Determined Cause: Other
• Action: Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
• Quantity in Commerce: 749
• Distribution: Nationwide, Argentina, Brazil, Canada, China, Chile, Egypt, India, Italy, Japan, Korea, Mexico, Pakistan, Panama, Philipines, Puerto Rico, Singapore, Spain, Thailand, Turkey, Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.