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Terminated

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.

FDA Recall Z-1537-2013 · Posted 2013-06-17

Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeMNT
Date Initiated2013-06-04
Date Terminated2014-04-24
Product Quantity19,200 units total (12,060 units in US)

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc. · 2011-04-05K082660V60 VENTILATOR, MODEL V8000Respironics California, Inc. · 2009-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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