Events

Recall of Philips V60 Ventilators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77084
  • Event Risk Class
    Class 1
  • Event Number
    Z-2061-2017
  • Event Initiated Date
    2017-04-24
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154944
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
  • Reason
    Over time, low-frequency vibrations can cause the pins within the female connectors on the motor controller to data acquisition board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.
  • Action
    The firm, Philips, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2017 to its customers. The Customers letter inform them that Respironics California is recalling the Philips V60 Noninvasive Ventilators manufactured before 15 September 2015; that the recall is for all V60s with date of manufacture before 15 September 2015 and not for V60 Ventilators manufactured on or after 15 September 2015; of the recall reason, risk to health, how to identify devices subject to recall, and actions to be taken the customers. The customers were also instructed to complete and return the RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: recall.response@philips.com or fax to: 1-877-499-7223 or mail to: Philips Healthtech, Mailstop# 4202, 3000 Minuteman Road, Andover, MA 01810-1032. On 5/9/17, Respironics has revised customer notification letter and began sending it out to their customers. The update includes the following actions to be taken: "appropriately trained personnel may continue using the V60" and "ensure an alternative form of ventilation device is available at all times, including intra-hospital transport (e.g. manual ventilation bag)." Philips will contact each consignee to schedule an appointment for this recall. Philip Engineers will remediate any affected V60 ventilators at the site. If you have any questions, please contact the Head of Q & R at 760-918-1067 or donald.sherratt@philips.com.

Device

Philips V60 Ventilators
  • Model / Serial
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, India, Indonesia, Iran (Islamic Republic Of), Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Malta, Mexico, Monaco, Morocco, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province Of China, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
  • Product Description
    Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617. || Old Material No. 850008, 989805628251, 989805612101, 989805613391, 989805613661, 989805611761, 989805627411, 989805627431, 989805627441, 989805616411, 989805636631.
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011-1517
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA