Events

Recall of Device Recall GE Healthcare Innova

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ge 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
    55445
  • Event Risk Class
    Class 2
  • Event Number
    Z-1661-2010
  • Event Initiated Date
    2010-03-24
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90872
  • 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
    Cardiovascular Imaging System - Product Code MQB
  • Reason
    A potential software failure related to the worklist functionality has been identified on a subset of innova 2100iq, 3100iq and 4100iq systems. when using the worklist function to import patient data to innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.
  • Action
    Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.

Device

Device Recall GE Healthcare Innova
  • Model / Serial
    0000009C2M0012 0000008C2M0005 0000009C2M0019 0000009C2M0017 0000009C2M0008 0000009C2M0015 0000009C2M0027 0000008C2M0002 0000009C2M0020 0000009C2M0048 0000009C2M0038 0000009C2M0050 0000009C2M0022 0000009C2M0051 0000009C2M0052 0000009C2M0011 0000009C2M0045 0000009C2M0086 0000009C2M0034 0000009C2M0073 0000009C2M0080 0000009C2M0066 0000009C2M0087 0000009C2M0070 0000009C2M0055 0000009C2M0061 0000009C2M0047 0000009C2M0091 0000009C2M0075 0000009C2M0031 0000009C2M0102 0000009C2M0094 0000009C2M0095 0000009C2M0103 0000009C2M0121 0000009C2M0069 0000009C2M0141 0000009C2M0135 0000009C2M0123 0000009C2M0159 0000009C2M0098 0000009C2M0146 0000009C2M0018 0000009C2M0153 0000009C2M0168 0000009C2M0145 0000009C2M0107 0000009C2M0142 0000009C2M0203 0000009C2M0114 0000009C2M0129 0000009C2M0170 0000009C2M0169 0000009C2M0182 0000009C2M0044 0000009C2M0125 0000009C2M0190 0000009C2M0201 0000009C2M0152 0000009C2M0140 0000009C2M0184 0000010C2M0001 0000009C2M0039 0000009C2M0035 0000009C2M0036 0000009C2M0043 0000009C2M0132 0000009C2M0151 0000009C2M0164 0000009C2M0172 0000009C2M0196 0000009C2M0207 0000009C2M0183 0000009C2M0206 0000009C2M0113 0000009C2M0105 0000009C2M0191 0000009C2M0174 0000009C2M0137 0000009C2M0133 0000009C2M0134 0000009C2M0138 0000009C2M0161 0000009C2M0181 0000009C2M0198 0000010C2M0016 0000009C2M0089 0000009C2M0204 0000009C2M0079 0000009C2M0186 0000009C2M0165 0000009C2M0076
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.
  • Product Description
    GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • Manufacturer
    Ge Healthcare, Llc

Manufacturer

Ge Healthcare, Llc
  • Manufacturer Address
    Ge Healthcare, Llc, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA