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U.S. Department of Health and Human Services

Class 2 Device Recall Kenex Radiation Shield

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 Class 2 Device Recall Kenex Radiation Shield see related information
Date Posted June 03, 2014
Recall Status1 Terminated on February 25, 2015
Recall Number Z-1706-2014
Recall Event ID 68219
Product Classification Shield, protective, personnel - Product Code KPY
Product 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.
Code Information 9588BU9 2722497
00000080201YY7 17815
FMI12198DUM003 39522
00000425901TU6 45999
00000438491WK3 48360-1
00000389587WK7 73959
00000230601BU7 49840
00000013686M31 XVE305-07
00000213765WK1 0045
00000997074WK0 1165109
00001000016WK4 2584562
00000004255GP6 25976
00000002481GP0 26009
00000206174BU5 48776
00000177999BU0 99299
00000590859BU5 2834771
00000585589BU5 2839767
0000TPAA333382 XVE303-11
FMI12198DUM006 75155
00000277200BU2 90690
00000593468BU2 1330402
FMI12209DUMM152 1343150
00000588006BU7 2834504
00000617212BU6 XV2359035
00000607207BU8 XV606948BU8
00000607627BU7 XV606949BU6
0000011C2M0214 XV607663BU2
FMI12209DUMM153 XVE3-05-25
FMI12209DUMM154 XVE311-35
00000599037BU9 XVE31411
00000623159BU1 XVNPC001306
00000583671BU3 2821384
00000343061BU8 BG4029VA01
00000569367BU6 BG4033VA01
00000556126BU1 BG4042VA01
00000588252BU7 BG4621VA01
0000013C2S0033 BG4549VA03
FMI12209DUMM107 BG4555VA01
00000636248BU7 BG4572VA01
00000546436BU7 BG4549VA02
00000619184BU5 BG4639RX01
00000426512BU0 BG4549VA01
00000609/70813 BG4604VA01
00000005059GP1 BG4029VA03
00000085519CX7 BG4597VA01
00000583121BU9 BG4009VA01
00000418039BU4 BG4037XR01
00000319990WK8 BG4000RX01
00000289189WK3 4165212S16
00000488568WK7 416522LCA
00000451080WK6 22105ANGI1
00000404765WK0 26863ANGI1
00000470061BU3 26814ANGI2
00000562718BU7 HSRINNOVA1
00000575046BU8 27305ANGI1
00000593054BU0 27826ANGI2
00000604695BU7 HCVANGI1
00000004001GP4 082416090001
00000273317BU8 082416200001
00000004304GP2 082416200003
00000403958BU2 082406140017
00000429955BU8 082406140020
00000371685BU9 082416010002
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00000439636BU2 082416010004
00000410337BU0 082416020001
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00000349889BU6 082416140001
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00000446999BU5 082416200006
00000388606BU6 082416210001
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00000424700BU3 082416220005
00000418277BU0 082416220007
00000387191BU0 082416250001
00000433754BU9 082416250003
00000397408BU6 082416270001
00000466823BU2 082416310004
00000472308BU6 082416310005
00000473100BU6 082416010005
00000537030BU9 082416010007
00000559116BU9 082416010008
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00000461410BU3 082416030004
00000485316BU4 082416030005
00000554130BU5 082416030011
00000008C20286 082416030012
00000460315BU5 082416040011
00000471653BU6 082416040012
00000469583BU9 082416040014
00000576422BU0 082416040029
00000473045BU3 082416050003
00000541064BU2 082416060001
00000008C20318 082416060003
00000512466BU4 082416070006
00000583478BU3 082416070007
00000589827BU5 082416070011
00000568034BU3 082416090003
00000575166BU4 082416090005
00000590064BU2 082416090010
00000461621BU5 082416100007
00000461622BU3 082416100009
00000509826BU4 082416100012
00000537464BU0 082416100014
00000513295BU6 082416100015
00000538573BU7 082416100017
00000559109BU4 082416100020
00000551078BU9 082416110005
00000470508BU3 082416120008
00000484906BU3 082416120009
00000569792BU5 082416120015
00000571897BU8 082416120016
00000485958BU3 082416130019
00000519626BU6 082416130023
00000518729BU9 082416130024
00000496756BU8 082416130026
00000570351BU7 082416130029
00000580875BU3 082416130031
00000586695BU9 082416130032
00000584109BU3 082416130033
00000548340BU9 082416140006
00000538
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
800-345-2700
Manufacturer Reason
for Recall
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 Determined
Cause 2
Equipment maintenance
Action GE Healthcare sent an "Urgent Medical Device Correction" letter # 12209 dated May 2, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected product Details, Product Correction and Contact Information. For questions they should call 1-800-345-2700. For other countries, they should contact their local GE Healthcare Service Representative. .
Quantity in Commerce 3221 (108 US, 3113 OUS).
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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