Z-2241-2009

Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188...

Name: Z-2241-2009 Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188...
Creator: GE Medical Systems, LLC
Published: 2009-07-31
License: https://open.fda.gov/license/

GE Healthcare / initiated 2009-07-31 / Terminated / root cause: design

FDA source

GE Medical Systems, LLC began a recall of Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane... on 2009-07-31. The reason FDA records is "GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2241-2009
Status: Terminated
Initiated: 2009-07-31
Posted: 2009-09-24
Terminated: 2012-05-15
Recalling firm: GE Healthcare
Product: Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: GE Healthcare has recently became aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.
Quantity in commerce: 6
Distribution: Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
Product codes and lots: 00000423793BU9 00000424103BU0 00000427535BU0 00000429845BU1 00000430039BU8 and 00000410867BU6.

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)