Skip to content

GE Healthcare Optima IGS 320 recallZ-1973-2015 · GE Healthcare · initiated May 29, 2015

Class II Terminated All recalls posted in July 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1973-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 29, 2015
Posted by the FDA
Jul 3, 2015
Recalling firm
GE Healthcare
Quantity
3
Product code
IZI
FDA submissions
K122457
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, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.

Product description

GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Code information (models, lots, serial numbers)

System ID  083016208011415  5512XR0025  5512XR0033

Other devices under the same FDA submission

1 device cleared under K122457 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 71508).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page