CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

Innova 2100IQ, Cardiovascular and Interventional Imaging System recalled

GE Healthcare is recalling Innova 2100IQ, Cardiovascular and Interventional Imaging System, distributed nationwide in the US. The recall was initiated on 21 Oct 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7

Quantity recalled48

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1142-2013
FDA event ID: 64884
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2011
FDA classified: 18 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

21 Oct 2011	Recall initiated by company
18 Apr 2013	Classified by FDA	+545 days
24 Apr 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover of the Gantry Pivot section. This safety label is missing on systems manufactured between March 2010 and July 2011. In the situation a staff member (doctor, nurse, operator, anesthetist, etc&) stands in the region between the C-arm gantry pivot and the head section of the table, there is a risk of co

Product as listed by the FDA

GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System.

Where it was distributed

Worldwide Distribution - Nationwide Distribution including the states of FL, IL, IN, LA, MI, MN, NJ, NM, NY, OH, PR, SC, TX and VA and the countries of Vietnam, Latvia, Italy, Israel, Indonesia, Hong Kong, United Kingdom, Finland, Spain, Czech Republic, Canada, Bahrain and Australia.

Nationwide Florida Illinois Indiana Louisiana Michigan Minnesota New Jersey New Mexico New York Ohio Puerto Rico South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number 00000000321WVO 00000000353WV3 00000000000000 00000000346WV7 00000000292WW3 00000000327WV7 00000000333WV5 00000000325WV1 00000000298WV0 00000000301WV2 00000000271WV7 00000000250WV1 00000000251WV9 00000000332WV7 00000000263WV4 00000000275WV8 00000000335WV0 00000000249WV3 00000000303WV8 00000000331WV9 00000000255WV0 00000000337WV6 00000000359WV0 00000000362WV4 00000000352WV5 00000000318WV6 00000000324WV4 00000000355WV8 00000000354WV1 00000000329WV3 00000000274WV1 00000000267WV5 00000000305WV3 00000000322WV8 00000000317WV8 00000000132WV1 00000000280WV8 00000000026WV5 00000000254WV3 00000000420WV0 00000000297WV2 00000XXX299WV8 00000000257WV6 00000000357WV4 00000000253WV5 00000000339WV2 00000000265WV9 00000000252WV7

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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