FDAClass IIJune 21, 2017

GE Healthcare Optima CT660 recall

GE Healthcare Optima CT660, CT680 X-ray system

Why was GE Healthcare Optima CT660 recalled?

It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

n/a

Product
GE Healthcare Optima CT660, CT680 X-ray system
Recalling firm
GE Healthcare, LLC
Quantity
10,884
Distribution
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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