Events

Recall of Device Recall Spacelabs Healthcare G2 Clinical Access CD

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
    67638
  • Event Risk Class
    Class 2
  • Event Number
    Z-1273-2014
  • Event Initiated Date
    2014-02-14
  • Event Date Posted
    2014-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125906
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Reason
    Spacelabs has voluntarily recalled g2 clinical access software cd because the programs installed on the clinical access cd are incorrect and it will prevent the customer from installing clinical access.
  • Action
    Spacelabs Healthcare began sending out the Medical Device Correction letter, dated 28 February 2014, to domestic customers on 28 February 2014 and to international customers by 7 March 2014. The letter identified the product, the product, the problem, and the action to be taken by the customer. Customers are also directed to call 1-800-522-7025 and select 2 for Technical Support. Customers are advised to dispose the CD, PN: 063-1829-11 Rev A previously supplied and replace it with the replacement CD (Rev B) provided.

Device

Device Recall Spacelabs Healthcare G2 Clinical Access CD
  • Model / Serial
    Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.  Serial numbers distributed in the US: "040-1565-10" and "063-1829-11".   Serial number distributed outside the US: "063-1829-11".
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
  • Product Description
    Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. || Used for installing ICS G2 Clinical Access software onto hospital personal computers.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

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