Class 1 Device Recall Esprit V1000 Ventilator, V200 Ventilator

• Date Initiated by Firm: September 17, 2014
• Date Posted: October 21, 2014
• Recall Status: Terminated on September 28, 2016
• Recall Number: Z-0008-2015
• Recall Event ID: 69313
• 510(K)Number: K981072 K001208 K023350 K034040
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits; ; Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
• Code Information: Serial Numbers: VS0002577 VS0002579 VS0002580 VS0002581 VS0002583 VS0002584 VS0002585 VS0002586 VS0002587 VS0002588 VS0002589 VS0002590 VS0002593 VS0002595 VS0002596 VS0002599 VS0002602 VS0002603 VS0002604 VS0002605 VS0002606 VS0002609 VS0002610 VS0002611 VS0002613 VS0002615 VS0002616 VS0002625 VS0002630 VS0002746 VS0002750 VS0002752 VS0002753 VS0002759 VS0002728 VS0002773 VS0002765 VS0002772 VS0002828 VS0002842 VS0002830 VS0002834 VS0002859 VS0002873 VS0002874 VS0002877 VS0002879 VS0002884 VS0002844 VS0002846 VS0002847 VS0002851 VS0002856 VS0002891 VS0002815 VS0002816 VS0002924 VS0002927 VS0002929 VS0002932 VS0002933 VS0002934 VS0002936 VS0002938 VS0002939 VS0002943 VS0002942 VS0002947 VS0002946 VS0002960 VS0002994 VS0002998 VS0002708 VS0002817 VS0002940 VS0002958 VS0002959 VS0002963 VS0003023 VS0003029 VS0003074 VS0003079 VS0003080 VS0003092 VS0003093 VS0003141 VS0003095 VS0003114 VS0003176 VS0003260 VS0003139 VS0003172 VS0003259 VS0003286 VS0003303 VS0003343 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• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 760-918-7300
• Manufacturer Reason for Recall: A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Philips Healthcare sent an Urgent - Field Safety Notice dated September 17, 2014, to all customers who purchased the Esprit V1000 and V200 Ventilators to inform them that Respironics is recalling Esprit V1000 and V200 Ventilators installed with 3rd Generation Power Supplies and also 3rd Generation Power Supply Repair Part Kits. The letter identifies the affected devices, informs the customers of the problems, hazard involved, and the actions to be taken. Customers were reminded to be advised of the warnings provided. A Philips Respironics representative will contact customers to schedule a no-cost replacement for further information or support. Customers with questions were instructed to contact Philips Healthcare at 1-800-722-9377. For questions regarding this recall call 760-918-7300.
• Quantity in Commerce: 2,206 units total (665 units in US)
• Distribution: Worldwide Distribution - USA, Argentina, China, Egypt, Ethiopia, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Jordan, Libyan Arab Yamahiriya, Malaysia, Mali, Mexico, Myanmar (Burma). Nepal, Nigeria. Pakistan, Peru, Philippines, Serbia, Singapore, South Africa, Sri Lanka, United Republic of Tanzania, Thailand, Vietnam, Zimbabwe, Republic of Korea, and Netherlands.
• 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 CALIFORNIA, INC.; 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.