CLASS II Device recall · Reported 10 Jul 2013 · FDA Enforcement Report

Innova 3100 and Innova 4100 systems recalled by GE Healthcare

GE Healthcare is recalling Innova 3100 and Innova 4100 systems, distributed in 14 states. The recall was initiated on 16 May 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4

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-1616-2013
FDA event ID: 65022
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 16 May 2011
FDA classified: 28 Jun 2013
Reported: 10 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

16 May 2011	Recall initiated by company
28 Jun 2013	Classified by FDA	+774 days
10 Jul 2013	Published in enforcement report	+12 days

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

Reason for recall

GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

Product as listed by the FDA

GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures.

Where it was distributed

Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.

Arizona California Colorado Florida Idaho Illinois Maine North Carolina Nevada New York Oklahoma Tennessee Utah Wisconsin

Questions about this recall

Why was it recalled?

GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.

Which lots are affected?

SERIAL NUMBER 00000007C20103 0000010C2M0069 0000010C2M0181 0000010C2M0214 0000010C2M0259 0000010C2M0137 0000010C2M0159 0000010C2M0262 0000009C2M0084 0000010C2M0130 0000010C2M0218 0000010C2M0297 0000009C2M0108 0000010C2M0236 0000009C2M0167 0000010C2M0208 0000010C2M0295 0000000DUMMY01 00000009C20099 00000007C20141 00000595660BU2 0000010C2M0063 0000010C2M0083 0000009C2M0041 0000010C2M0180 0000010C2M0189 0000010C2M0174 00000593054BU0 00000007C20150 0000010C2M0027 0000010C2M0121 0000010C2M0229 0000010C2M0253 0000010C2M0122 0000010C2M0005 00000007C20173 0000009C2M0040 0000009C2M0077 0000010C2M0088 0000010C2M0097 0000010C2M0143 0000010C2M0192 0000010C2M0193 0000010C2M0204 0000010C2M0294 0000010C2M0269 0000010C2M0176 00000498682BU4

Where was it sold?

Worldwide distribution - USA including AZ, CA, CO, FL, ID, IL, ME, NV,NY, NC, OK, TN, UT, and WI; and Internationally to Canada, Chile, France, Germany, Italy, Japan, Korea, Norway and Spain.

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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