CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Optima CT520 X-ray system recalled by GE Healthcare

GE Healthcare is recalling GE Healthcare Optima CT520 X-ray system, distributed nationwide in the US. The recall was initiated on 19 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesn/a

Quantity recalled10,884

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2185-2017
FDA event ID: 77377
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 19 May 2017
FDA classified: 12 Jun 2017
Reported: 21 Jun 2017
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 May 2017	Recall initiated by company
12 Jun 2017	Classified by FDA	+24 days
21 Jun 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

GE Healthcare Optima CT520 X-ray system

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Optima CT520 X-ray system recalled?

Yes. GE Healthcare recalled Optima CT520 X-ray system on 19 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2185-2017.

Why was it recalled?

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

Which lots are affected?

n/a

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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