Events

Recall of Device Recall Siemens RAPEDPoint500

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
    74564
  • Event Risk Class
    Class 3
  • Event Number
    Z-2601-2016
  • Event Initiated Date
    2016-07-05
  • Event Date Posted
    2016-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147912
  • 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
    Acid, lactic, enzymatic method - Product Code KHP
  • Reason
    Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the united states.
  • Action
    Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.

Device

Device Recall Siemens RAPEDPoint500
  • Model / Serial
    Software Version 2.2A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
  • Product Description
    Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A || The RAPIDPoint 500 system is designed 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. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
  • 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