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GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is...

FDA Recall #Z-1616-2013 — Class II — May 16, 2011

Recall #Z-1616-2013 Date: May 16, 2011 Classification: Class II Status: Terminated

Product Description

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.

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.

Recalling Firm

GE Healthcare, LLC — Waukesha, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

48

Distribution

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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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