Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
FDA Recall Z-0211-2015 · Posted 2014-11-13
Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeDTQ
Date Initiated2014-10-17
Date Terminated2016-04-06
Product Quantity331 units
Reason for Recall
Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
Firm Action
Maquet Inc. sent a Product Recall Urgent Medicall Device Field Correction letter to all of their customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter stated that a software upgrade will be performed by an authorized Maquet Service Technician. A Maquet representative will contact customer to schedule an on-site service of the device. Any questions can be directed to the local Maquet representative or Maquet Customer Service at 1-888-627-8383 (option 2, option 2) Monday through Friday, between the hours of 8:00 am and 6:00 pm (EST).
Root Cause
Software Design Change
Distribution Pattern
Worldwide Distribution - US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.