Events

Recall of Device Recall 91496 Ultraview SL Command Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare 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
    74549
  • Event Risk Class
    Class 2
  • Event Number
    Z-2343-2016
  • Event Initiated Date
    2016-07-01
  • Event Date Posted
    2016-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147885
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    The firm has received multiple reports of the non-invasive blood pressure (nibp) parameter becoming non-functional with an associated message (no reading). in addition, there is one of the following three error messages: inflate error, hw error, or no data.
  • Action
    Spacelabs expanded the recall and sent an Urgent - Medical Device Correction letter dated August 30, 2016, to additional affected customers via priority mail (return receipt requested). On September 6, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. ********************************************************************************************** Spacelabs Healthcare Inc, sent an Urgent - Medical Device Correction letter dated July 1, 2016, to all affected customers (return receipt requested). On July 8, 2016, a customer letter (translated as necessary) was sent via email to all international subsidiaries and distributors of record. Spacelabs Healthcare will contact customers to schedule a convenient time for a Spacelabs service technician to update their affected Command Module(s) at no cost. For additional information or technical assistance, please contact: Technical Support 1-800-522-7025 and select (2) for Technical Support

Device

Device Recall 91496 Ultraview SL Command Module
  • Model / Serial
    Manifold Lot Codes: 128280, 129420, 129940, or 155640.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Distribution and to the countries of : AFGHANISTAN, ARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM; CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DOMINICAN REPUBLIC; ECUADOR, EGYPT, ESTONIA, FRANCE, GERMANY, GUATEMALA, HONG KONG, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JORDAN, KUWAIT, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, PAKISTAN, PALESTINE, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, Slovakia, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
  • Product Description
    91496 Ultraview SL Command Module, Options A, B, C, and I. || Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. || Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. || Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. || Option I: SpO2, Temperature x2, & adult/neonate NIBP.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Manufacturer Address
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA