Events

Recall of RAPIDPoint 500 Blood Gas Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics 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
    76981
  • Event Risk Class
    Class 2
  • Event Number
    Z-2040-2017
  • Event Initiated Date
    2017-04-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154759
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    Potential patient demographic error with blank patient id field.
  • Action
    Siemens Healthcare issued an An Urgent Field Safety Notice via e-mail to all affected Siemens Healthcare Diagnostics Regional offices on April 10, 2017 both in the United States and outside of the United States. This notice informs customers of the issue, risk to health and actions to be taken by the customer. A Field Correction Effectiveness Check form to be completed and returned. Questions: Contact your Siemens Customer Care Center or your local Siemens technical support representative

Device

RAPIDPoint 500 Blood Gas Analyzer
  • Model / Serial
    Serial Numbers: 30762 32470 33999 35395 36284 39672 40405 40456 40508 30779 33198 34000 35462 37243 39688 40406 40460 40509 30784 33201 34082 35688 37261 39689 40407 40461 40510 30819 33232 34083 35690 37275 39690 40408 40464 40512 30841 33370 34291 35692 37292 39691 40409 40466 40561 30842 33438 34427 35693 37295 39692 40410 40467 40562 30844 33459 34438 35703 37296 39693 40411 40468 40565 30846 33573 34442 35705 37563 39694 40412 40469 40568 30904 33640 34444 35922 38110 39695 40413 40470 40576 30905 33643 34627 36003 38138 39698 40421 40471 40580 30906 33863 35002 36005 38306 39699 40422 40473 40582 30907 33865 35009 36006 38815 39700 40427 40477 40583 31006 33968 35053 36007 39301 39701 40436 40489 40594 31771 33986 35055 36008 39303 39702 40437 40501 40596 31772 33997 35195 36113 39459 39703 40448 40502 40612 32356 33998 35393 36116 39597 40403 40451 40503 40616 40624 40625 40642 40643 40644 40647 40648 40666 40669 40677 40678 40679 40748 40806 313388
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay
  • Product Description
    RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. || Siemens SMN numbers: 10492730, 10696857, 10697306
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA