Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray…
Medical device recall Z-1706-2014. Published in FDA’s Enforcement Report on Jun 11, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 11, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 3221 (108 US, 3113 OUS). how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceil
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
3221 (108 US, 3113 OUS)., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV…
Every code shown here, 1,987 characters
Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV 00000063736YY3 MCTHKGMN 00000416503WK1 1222 00000299868WK0 215662C3 00000312304WK9 215770C1 00000367696WK2 215861LC 00000312714WK9 301891LC 00000321508WK4 313421LC 00000309562WK7 317818MDI120 00000438039WK0 317818MDI905 00000503165WK3 318462BCL 00000505246WK9 318473RCATH4 00000281715WK3 318494LC1 00000405780WK8 318494LC2 00000405779WK0 401729PCL 00000455944WK9 402280P1 00000492511WK1 407646CL1 00000314328WK6 407896CCCATH 00000378033WK5 480474LC3 00000314429WK2 607763CL1 00000469188WK7 610250SC 00000399463WK9 615778ECL1 00000431048WK8 615781SHCV1 00000466434WK8 617340LC 00000280718WK8 618242GSLC 00000323794WK8 619543UC5 00000409286WK2 636933JMLC 00000320222WK3 708383OPLC 00000506007WK4 801350LC1 00000508243WK3 801350LC2 00000309699WK7 815963LC 00000285416WK4 817548ALC 00000273308BU7 901384LCA 00000399610WK5 909824LC2 00000421718WK8 909824LC3 00000475337WK2 910343NHC1 00000373273WK2 941475CL 00000504090WK2 DLPGMH1 00000283982WK7 E16327 00000432874WK6 LIJ201178 00000484098WK9 M27036 00000336973WK3 MCTH050 FMI12209DUM168 NSCXR 00000387613WK3 215221CL3 00000423269WK0 215785SCA 00000500248WK0 813462ADV1 00000215082WK9 316268SFCL 00000249758WK4 713791SCL3X 00000470720WK4 305395B44 00000319310WK9 313745CATH2 00000414277WK4 415428OCCL2 00000459249WK9 507255CC101 00000409553WK5 602258LC1 00000450389WK2 619552VLC 00000293241WK6 808547QRM8A 00000496418WK5 912633MCL1 00000495821WK1 916734XR 00000289981WK3 M27037 00000497122WK2 215221CL1 00000143391WK1 0837YX0037 00000298765WK9 203872LUA 00000389718WK8 404422NR5 00000305860WK9 619421XSP 00000287562WK3 704255MMS2 00000315705WK4 714824LUA 00000227510WK5 714887LU 00000295578WK9 7186155N47 FMI12198DUM051 801566SPC 00000450489WK0 810664LUA 00000071592WK0 919748B10 00000286172WK2 214872NSP…
FDA’s list runs to 84,502 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, VENEZUELA, VIETNAM, and YEMEN.
The states and territories these words name
- Georgia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 2, 2014.
- FDA classified it on Jun 3, 2014.
- FDA’s Enforcement Report published it on Jun 11, 2014.
- FDA terminated it on Feb 25, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 84,502 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.