Events

Recall of CARDIOHELPi

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Medical Systems USA.

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
    66336
  • Event Risk Class
    Class 2
  • Event Number
    Z-0082-2014
  • Event Initiated Date
    2013-09-12
  • Event Date Posted
    2013-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122075
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    It has come to the attention of maquet that in certain rare instances, the cardiohelp-i device may display an error message with audible alarm, indicating "battery defective." the alarm will occur-upon start up or when the main power supply is unplugged from the main power source. the human machine interface touch screen of the cardiohelp-i device may gradually become black due to the human machine interface (hmi) back light shutting down.
  • Action
    MAQUET issued their customers "Urgent-Medical Device Field Correction" notices/Customer Fax Response forms dated September 16, 2013 via FedEx on September 16, 2013. The notification informs the customer of the issue with the product; how to identified affected product; and the action needed to be taken by the customer. The field correction includes service on the affected product. Authorized MAQUET Service Technicians will service the affected product to correct the issue. Customers were requested to complete and fax back (or email a scanned copy) of the enclosed response form. Customers could contact their local field representative or the MAQUET Customer Service line at 1.888.627.8383 (press option 2 followed by option 2) Monday through Friday, 8am to 6pm EST. For questions regarding this recall call 973-709-7000.

Device

CARDIOHELPi
  • Model / Serial
    Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533;  90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, FL, CO, TX, OH, VA, MN, WI, SC, IL, ND, UT, CA, OR, NY, IA, CT, SD, MI, HI, AL, MD, KS, MO
  • Product Description
    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. || Cardiopulmonary support system.
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA
  • Manufacturer Address
    Maquet Medical Systems USA, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA