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U.S. Department of Health and Human Services

Class 1 Device Recall V60 Ventilator

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 Class 1 Device Recall V60 Ventilator see related information
Date Posted June 17, 2013
Recall Status1 Terminated on April 24, 2014
Recall Number Z-1537-2013
Recall Event ID 65376
510(K)Number K082660  K102985 
Product Classification Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
Product Respironics V60 Ventilator, Model #V60

Respironics Material P/N (Philips 12 Digit P/N):

85008 (85008)
1053613 (989805628251)
1053614 (989805612101)
1053615 (989805613391)
1053616 (989805613661)
1053617 (989805611761)
1053618 (n/a)
R1053618 (n/a)
1076709 (n/a)
1076715 (989805627411)
1076716 (989805627431)
1076717 (989805627441)
DU1053617 (989805616411)
U1053614 (989805636441)
U1053617 (989805636631)

Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581.

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 lbs.) 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 013
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10
Recalling Firm/
Manufacturer
Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92011-1517
760-918-7300
For Additional Information Contact
760-918-7300
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action The firm, Philips Healthcare, sent a "MEDICAL DEVICE CORRECTION" letter dated June 3, 2013 to all customers who received the V60 Ventilators. The letter describes the product, problem identified and the actions to be taken. The customers were informed that the V60 ventilator may continue to be used in accordance with its directions for use, pending the completion of the update. In addition, the customers were instructed to refer to their manual for additional information on warnings. A Philips Field Service Engineer, Approved Sevice Provider or Distributor will be contacting the 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. If you need any further information or support concerning this issue, contact your local Philips Respironics representative at (800) 722-9377.
Quantity in Commerce 19,200 units total (12,060 units in US)
Distribution Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt , Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Kenya, Kuwait, Lebanon, Libya, Malaysia, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Utd.Arab.Emir. and Vietnam.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
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