Events

Recall of Device Recall Shape Disposable Patient Interface

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Shape Medical Systems, 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
    70149
  • Event Risk Class
    Class 2
  • Event Number
    Z-1060-2015
  • Event Initiated Date
    2014-12-23
  • Event Date Posted
    2015-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132323
  • 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
    Calculator, predicted values, pulmonary function - Product Code BTY
  • Reason
    This recall has been initiated because use of the impacted dpis could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. the magnitude of error for vo2 or vco2 parameters could be approximately 20% with use of the impacted product.
  • Action
    An Urgent Medical Device Recall letter was mailed to consignees on 12/23/2014. The letter identified affected product, described the issue and asked for product to be returned. Shape Technical Service will contact customers to assist in the return of product. A response form was asked to be returned. Customers with questions can call Shape Technical Service at 1-888-906-6266.

Device

Device Recall Shape Disposable Patient Interface
  • Model / Serial
    Lot Numbers: 1412001, 1412002, 1412003 and 1412004
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.
  • Product Description
    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. || The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.
  • Manufacturer
    Shape Medical Systems, Inc

Manufacturer

Shape Medical Systems, Inc
  • Manufacturer Address
    Shape Medical Systems, Inc, 5000 Township Pkwy, Saint Paul MN 55110-5852
  • Manufacturer Parent Company (2017)
    Shape Medical Systems Inc.
  • Source
    USFDA