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-1660-2010
  • 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=90871
  • 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
    0000008C2M0006 0000008C2M0003 0000009C2M0029 0000009C2M0014 0000009C2M0028 0000009C2M0057 0000009C2M0049 0000009C2M0013 0000009C2M0040 0000009C2M0025 0000009C2M0023 0000009C2M0041 0000009C2M0021 0000009C2M0046 0000009C2M0033 0000009C2M0058 0000009C2M0053 0000009C2M0056 0000009C2M0060 0000009C2M0150 0000009C2M0062 0000009C2M0009 0000009C2M0030 0000009C2M0064 0000009C2M0054 0000009C2M0042 0000009C2M0068 0000009C2M0059 0000009C2M0010 0000009C2M0016 0000009C2M0074 0000009C2M0096 0000009C2M0088 0000009C2M0090 0000009C2M0104 0000009C2M0077 0000009C2M0063 0000009C2M0148 0000009C2M0101 0000009C2M0067 0000009C2M0157 0000009C2M0156 0000009C2M0175 0000009C2M0111 0000009C2M0120 0000009C2M0128 0000009C2M0127 0000009C2M0131 0000009C2M0130 0000009C2M0147 0000009C2M0097 0000009C2M0110 0000009C2M0118 0000009C2M0192 0000009C2M0119 0000009C2M0160 0000009C2M0177 0000009C2M0205 0000009C2M0209 0000010C2M0011 0000009C2M0071 0000009C2M0178 0000009C2M0185 0000009C2M0082 0000009C2M0081 0000009C2M0126 0000009C2M0122 0000009C2M0180 0000009C2M0197 0000009C2M0109 0000009C2M0112 0000009C2M0115 0000010C2M0002 0000010C2M0006 0000009C2M0139
  • 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 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The 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