Reported Aug 29, 2018 · Terminated

GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA…

GE Healthcare Japan Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare Japan Corporation · Ge Herusukea.Japan ( Kabu -4 Chome 7-127 · Hino · N/A

Is this the product you have?

  • GE Healthcare Optima CT660
  • Sold under the following product names

    150 of 150 codes

    • BEIJING OPTIMA CT660 PRO GT170
    • BEIJING OPTIMA CT660 PRO GT200
    • BEIJING OPTIMA CT660S PRO 32 S
    • CT GOLDSEAL
    • CT GOLDSEAL OPTIMA 660
    • CT GOLDSEAL OPTIMA 660 UT-BUC
    • CT OPTIMA 660 LNG HN P20
    • CT OPTIMA 660 MID HN P20
    • CT OPTIMA 660 PRO
    • CT OPTIMA 660 PRO LONG BJG P2
    • CT OPTIMA 660 PRO MID
    • CT OPTIMA 660 PRO MID HN P20
    • CT OPTIMA 660S LNG HN P20
    • CT OPTIMA CT660 GT 1700
    • CT OPTIMA CT660 GT1700
    • CT OPTIMA CT660 GT1700V
    • CT OPTIMA CT660 PRO GT1700
    • CT OPTIMA CT660 PRO LNG P1.5 H
    • CT OPTIMA CT660 PRO MID P1.5 H
    • CT OPTIMA CT660 SE GT 1700
    • CT OPTIMA CT660 SE GT2000
    • CT660
    • CT660 ASIR OPT
    • OPT CT660 FREEDOM GT1700 MKE25
    • OPT CT660 FREEDOM GT1700 MKE25
    • OPT CT660 FREEDOM GT2000 MKE25
    • OPTI660_A_G_1.5
    • OPTI660_A_L_2.0
    • OPTI660_N_G_1.5
    • OPTI660_N_G_2.0
    • OPTI660_N_L_2.0
    • OPTIMA 660 DIVA
    • OPTIMA 660 LNG HN P20
    • OPTIMA 660 LNG HN P20
    • OPTIMA 660 LONG
    • OPTIMA 660 LONG BJG P2.0
    • OPTIMA 660 LONG WSO
    • OPTIMA 660 MID
    • OPTIMA 660 MID BJG P1.5
    • OPTIMA 660 MID HN P20
    • OPTIMA 660 MID HN P20
    • OPTIMA 660 MID WSO
    • OPTIMA 660 PRO LGN HN P20
    • OPTIMA 660 PRO LONG BJG P1.5_
    • OPTIMA 660 PRO LONG BJG P2
    • OPTIMA 660 PRO LONG BJG P2.0
    • OPTIMA 660 PRO LONG BJG P2.0
    • OPTIMA 660 PRO LONG WSO
    • OPTIMA 660 PRO MID BJG P1.5
    • OPTIMA 660 PRO MID BJG P2.0
    • OPTIMA 660 PRO MID H
    • OPTIMA 660 PRO MID HN P20
    • OPTIMA 660 PRO MID WSO
    • OPTIMA 660 WSO
    • OPTIMA 660S 32 OPTIMA 660S 32 SLICE LONG WSO
    • OPTIMA 660S 32 SLICE MID WSO
    • OPTIMA 660S LNG HN P20
    • OPTIMA 660S MID BJG P2.0
    • OPTIMA 660S PRO 32 SLICE M WSO
    • OPTIMA 660S PRO LONG BJG P2.0
Lot codes and dates
  • Model Number
  • Serial Number (System ID)

    1,595 of 1,595 codes

    • 5454001-220
    • 00000296364HM3 (910212220)
    • 5454001-222
    • 00000316775HM6 (910216062)
    • 5454001-222
    • 00000316560HM2 (GF1001CT02)
    • 5454001-222
    • 00000312787HM5 (190163CT01)
    • 5454001-200
    • 00000296053HM2 (M2842586)
    • 5454001-222
    • 00000312788HM3 (M9024415)
    • 5454001-220
    • 00000302025HM2 (M4189263)
    • 5454001-222
    • 00000316776HM4 (600118CT01)
    • 5454001-222
    • 00000305880HM7 (X140985807)
    • 5454001-100
    • 427331CN4 (412357CT)
    • 5454001-100
    • 424963CN7 (334826CT)
    • 5454001-100
    • 373759GE0 (303LA660CT)
    • 5454001-100
    • 428253CN9 (SHICT01432)
    • 5454001-22
    • 51941YC3 (406434660)
    • 5454001-100
    • 423901CN8 (201488OPT660)
    • 5454001-100
    • 424944CN7 (516422CT660)
    • 5454001-122
    • 00000431995CN0 (405473CT1)
    • 5454001-222
    • 379369HM2 (864797OPT)
    • 5454001-100
    • 424968CN6 (864482CT660)
    • 5454001-122
    • 432338CN2 (703825OP660)
    • 5454001-222
    • 325767HM2 (757388CT)
    • 5454001-222
    • 00000316792HM1 (910212229)
    • 5454001
    • 00000026201YC4 (83021000510515)
    • 5454001
    • 00000026844YC1 (IL1000CT02)
    • 5454001
    • 00000033401YC1 (A5634107)
    • 5454001
    • 00000039355YC3 (850210791)
    • 5454001
    • 00000029121YC1 (850210732)
    • 5454001
    • 00000037278YC9 (850210764)
    • 5454001-22
    • 00000058550YC5 (850210858)
    • 5454001-22
    • 00000066104YC1 (850210865)
Amount recalled
4,007 devices total (products 1, 2, 3)

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2020 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.