Events

Recall of Noncontinuous ventilators

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, 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
    45545
  • Event Risk Class
    Class 2
  • Event Number
    Z-1088-2008
  • Event Initiated Date
    2007-10-15
  • Event Date Posted
    2008-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66525
  • 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
    ventilation accessories - Product Code MNS
  • Reason
    Foreign material: glass fragments may present in the plastic bag material used to ship components.
  • Action
    The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.

Device

Noncontinuous ventilators
  • Model / Serial
    Lot Numbers 071010, 071011, and 071012.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped nationwide to medical facilities.
  • Product Description
    Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o modem US/CAN model number 1002816; d) Tranquility Ultrafine Qty 1 model number 1039671; and e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8550
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA