Events

Recall of Device Recall Ultraview SL Capnography Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Llc.

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
    58811
  • Event Risk Class
    Class 2
  • Event Number
    Z-2573-2011
  • Event Initiated Date
    2011-05-12
  • Event Date Posted
    2011-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100345
  • 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
    Monitor, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    Capnography module, model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. this reset clears the ram and the module returns to default settings.
  • Action
    Spacelabs Medical sent a "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 12, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken. Customers were recommended to set all their Capnography Module Configuration Manager alarm settings to "ON". The letter also recommended that customers brief their staff about the possibility of losing changes to the default settings and to restore them after a power interruption. A field service engineer will be contacting customers to set up a date and time when affected modules can be upgraded at no cost to the customer. For questions about this corrective action program, call Spacelabs Medical at 1-800-522-7025, Select 2 for Technical Support. For outside the US, customers can call 1-425-657-7200, x5089.

Device

Device Recall Ultraview SL Capnography Module
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of ALGERIA, ARGENTINA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA,COLOMBIA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, ISRAEL, ITALY, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PALESTINE, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, REPUBLIC OF CHINA, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and VIET NAM.
  • Product Description
    The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. || Mainstream monitoring uses a self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight (<14 grams), or single-use airway adapters are available for both adult and neonatal (low dead space) patients. || Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tubes using the mainstream function of the module. || The intended use statement that apply to the 91517 are continuous monitoring of carbon dioxide and oxygen. The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (i.e., clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Manufacturer Address
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA