CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

CT Goldseal Optima CT recalled by GE Healthcare

GE Healthcare is recalling CT Goldseal Optima CT 600, distributed nationwide in the US. The recall was initiated on 24 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 51941YC3, System ID Number 406434660

Quantity recalled42 units 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-2583-2018
FDA event ID: 80484
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 24 May 2018
FDA classified: 31 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 May 2018	Recall initiated by company
31 Jul 2018	Classified by FDA	+68 days
8 Aug 2018	Published in enforcement report	+8 days

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

Reason for recall

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CT Goldseal Optima CT 600

Where it was distributed

Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

Nationwide Alabama California Colorado Florida Illinois Indiana Massachusetts Maryland Michigan Mississippi North Carolina New Jersey New York Ohio Oklahoma South Carolina Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).

Which lots are affected?

Serial Number 51941YC3, System ID Number 406434660

Where was it sold?

Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.

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

9 other products · FDA event 80484

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018	CLASS II	Revolution EVO 3.6, labeled as recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Discovery MI Digital Ready recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Discovery IQ 2.0, 4 ring recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Optima CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Optima CT recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Revolution CT 160 1.5D STD WAUK recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Discovery MI, labeled as Discovery DMI 3 ring recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	Discovery RT labeled as recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide
8 Aug 2018	CLASS II	CT Goldseal BrightSpeed 16 PWR TIO 2 YR recalled by GE Healthcare	GE Healthcare	Device Malfunction	Nationwide

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All 512

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