GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Vi

FDA device recall Z-0947-2013 · posted 2013-03-13 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.

Action taken

GE Healthcare sent "URGENT MEDICAL DEVICE CORRECTION" letters dated January 18, 2013 and February 11, 2013 to all affected customers. The letters were addressed to Hospital Administrators / Risk Managers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The second letter dated February 11, 2013 was sent out to consignees which incorporated an additional model number (2270677-2) which was initially missed. Contact the firm 800-437-1171 for questions regarding these letters.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQB

Quantity affected

297

Distribution

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA,

Date initiated

2013-01-21

Date posted

2013-03-13

Date terminated

2014-01-16

Location

Waukesha, WI

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