Z-1921-2010

Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human...

Name: Z-1921-2010 Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human...
Creator: Ge Healthcare, Llc
Published: 2010-06-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2010-06-03 / Terminated / root cause: design

FDA source

Ge Healthcare, Llc began a recall of Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and... on 2010-06-03. The reason FDA records is "GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety". 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-1921-2010
Status: Terminated
Initiated: 2010-06-03
Posted: 2010-06-29
Terminated: 2015-09-28
Recalling firm: GE Healthcare
Product: Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: GE Healthcare has become aware of a potential loss of gantry and table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ systems with InnovaIQ Table that may impact patient safety.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent on 6/3/10 a GE Healthcare "Urgent Medical device Correction" letter dated May 12, 2010. The letter was addressed to Hospital Administrators/ Risk Mangers, Managers of Radiology/Cardiology and Radiologists/ Cardiologists. The letter included the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. Customers are to contact a service representative immediately if they notice any cable damage.
Quantity in commerce: 10
Distribution: Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, and WI and countries of UNITED KINGDOM, SWEDEN, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, ITALY, ISRAEL, IRELAND, INDIA, HONG KONG, GERMANY, FRANCE, FINLAND, CZECH REPUBLIC, and AUSTRALIA.
Product codes and lots: 00000553797BU2, 00000000075WV2, 00000000112WV3, 00000000153WV7, 00000000146WV1, 00000000023WV2, 00000000162WV8, 00000000079WV4, 00000000149WV5, and 00000000033WV1.

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)