Z-1659-2010

GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists...

Name: Z-1659-2010 GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists...
Creator: Ge Healthcare, Llc
Published: 2010-03-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-03-24 / Terminated / root cause: software

FDA source

Ge Healthcare, Llc began a recall of GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or... on 2010-03-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1659-2010
Status: Terminated
Initiated: 2010-03-24
Posted: 2010-05-26
Terminated: 2013-05-21
Recalling firm: GE Healthcare
Product: GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 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)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 28
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 codes and lots: 0000009C2M0037 0000009C2M0007 00000008C2M001 0000009C2M0032 0000009C2M0154 0000009C2M0065 0000009C2M0072 0000009C2M0078 0000009C2M0084 0000009C2MOO84 0000009C2M0085 0000009C2M0143 0000009C2M0136 0000009C2M0163 0000009C2M0100 0000009C2M0162 0000009C2M0117 0000009C2M0167 0000009C2M0093 0000009C2M0166 0000009C2M0171 0000009C2M0187 0000009C2M0144 0000009C2M0106 0000009C2M0199 0000009C2M0200 0000010C2M0005 0000009C2M0024

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)