GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human a

FDA device recall Z-1976-2015 · posted 2015-07-03 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

Action taken

The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

IZI

Quantity affected

13

Distribution

Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHI

Date initiated

2015-05-29

Date posted

2015-07-03

Date terminated

2015-10-28

Location

Waukesha, WI

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