CLASS II ONGOING Device recall · Reported 26 Jun 2019 · FDA Enforcement Report

Optima PET/CT 560, 560FX recalled by GE Healthcare

GE Healthcare is recalling Optima PET/CT 560, 560FX, distributed nationwide in the US. The recall was initiated on 12 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCT 560, 560FX

Quantity recalled1113 in total

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-1747-2019
FDA event ID: 82982
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 12 Feb 2019
FDA classified: 19 Jun 2019
Reported: 26 Jun 2019
Type: FDA Mandated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

12 Feb 2019	Recall initiated by company
19 Jun 2019	Classified by FDA	+127 days
26 Jun 2019	Published in enforcement report	+7 days

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

Reason for recall

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Product as listed by the FDA

Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure

Which lots are affected?

CT 560, 560FX

Where was it sold?

Nationwide Distribution

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

Other products in this recall event

5 other products · FDA event 82982

This product is part of a recall event; the main page for the event is Discovery Ml DR recalled by GE Healthcare.

Reported	Class	Recall	Company	Reason	Where
26 Jun 2019	CLASS II	Discovery Ml DR recalled by GE Healthcare	GE Healthcare	Other	Nationwide
26 Jun 2019	CLASS II	Discovery Ml recalled by GE Healthcare	GE Healthcare	Other	Nationwide
26 Jun 2019	CLASS II	Discovery PET/CT recalled by GE Healthcare	GE Healthcare	Other	Nationwide
26 Jun 2019	CLASS II	Discovery PET/CT recalled by GE Healthcare	GE Healthcare	Other	Nationwide
26 Jun 2019	CLASS II	Discovery IQ recalled by GE Healthcare	GE Healthcare	Other	Nationwide

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All 512

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