Events

Recall of Device Recall Shape HF Cardiopulmonary System

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
    68581
  • Event Risk Class
    Class 2
  • Event Number
    Z-2051-2014
  • Event Initiated Date
    2014-05-28
  • Event Date Posted
    2014-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128263
  • 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
    Shape medical has initiated a correction due to a mandatory software upgrade for the shape hf cardiopulmonary testing system prior to use of the impacted dpi lot numbers. use of the incorrect software version with the impacted dpis could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.
  • Action
    Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.

Device

Device Recall Shape HF Cardiopulmonary System
  • Model / Serial
    DPIs with Lot Number 1405006 and higher.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.
  • 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