Class 1 Device Recall V60 Ventilator

• Date Initiated by Firm: July 31, 2012
• Date Posted: August 31, 2012
• Recall Status: Terminated on March 22, 2013
• Recall Number: Z-2260-2012
• Recall Event ID: 62848
• 510(K)Number: K082660 K102985
• Product Classification: Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
• Product: V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490; ; Product Usage:; The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
• Code Information: Seria Numbers: 100026615 100029321 100029838 100030462 100030832 100026808 100029324 100029841 100030463 100030833 100026826 100029325 100029843 100030464 100030834 100027107 100029327 100029845 100030466 100030836 100027181 100029328 100029847 100030468 100030838 100027189 100029330 100030043 100030469 100030840 100027544 100029334 100030106 100030471 100030843 100027660 100029337 100030107 100030472 100030844 100027751 100029455 100030111 100030473 100030845 100027870 100029456 100030112 100030474 100030847 100027872 100029459 100030113 100030475 100030850 100027875 100029462 100030115 100030481 100030977 100028047 100029473 100030117 100030482 100030979 100028053 100029474 100030118 100030485 100030980 100028069 100029500 100030119 100030591 100030983 100028249 100029504 100030120 100030593 100030985 100028324 100029505 100030121 100030594 100030986 100028328 100029507 100030133 100030595 100030987 100028334 100029508 100030204 100030596 100030989 100028339 100029512 100030212 100030608 100030990 100028570 100029514 100030215 100030609 100030991 100028665 100029515 100030216 100030612 100030992 100028666 100029516 100030217 100030618 100030994 100028673 100029518 100030220 100030620 100030995 100029074 100029520 100030223 100030762 100030996 100029116 100029524 100030224 100030766 100030997 100029119 100029525 100030226 100030767 100030998 100029215 100029672 100030229 100030768 100031004 100029217 100029679 100030337 100030769 100031071 100029220 100029684 100030342 100030771 100031072 100029223 100029685 100030343 100030773 100031084 100029224 100029690 100030344 100030778 100031085 100029241 100029691 100030345 100030779 100031089 100029242 100029692 100030349 100030780 100031143 100029243 100029698 100030355 100030781 100031144 100029313 100029832 100030359 100030782 100031147 100029316 100029833 100030456 100030823 201002392 100029318 100029835 100030457 100030825 100029319 100029836 100030458 100030827 100029320 100029837 100030459 100030829
• Recalling Firm/ Manufacturer: Respironics California Inc; 2271 Cosmos Ct; Carlsbad CA 92011-1517
• For Additional Information Contact: 760-918-7300
• Manufacturer Reason for Recall: Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio
• FDA Determined Cause: Nonconforming Material/Component
• Action: Respironics California a division of Philips Healthcare sent a Medical Device Correction letter dated July 31, 2012 to all affected customers. The letter identified the affected product, problem identified and actions to be taken. The letter states that a Phillips Respironics Field Service Engineer or distributor will be contacting customers to schedule a no-cost replacement of the blower motor assembly on all affected V60 ventilators. For information or support concerning the recall issue, contact Philips Respironics at (800) 722-9377.
• Quantity in Commerce: 197 units total (116 in the US)
• Distribution: Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.
• 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 = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.; 510(K)s with Product Code = MNT and Original Applicant = Respironics Inc.