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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 Initiated by Firm May 02, 2014
Date Posting Updated June 03, 2014
Recall Status1 Terminated 3 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, 00000394046BU7 082416010003, 00000439636BU2 082416010004, 00000410337BU0 082416020001, 00000397645BU3 082416020002, 00000359558BU4 082416030001, 00000444688BU6 082416030002, 00000334724BU2 082416040002, 00000334723BU4 082416040003, 00000348540BU6 082416040004, 00000366741BU7 082416040005, 00000428398BU2 082416040007, 00000424821BU7 082416040008, 00000468130BU0 082416040013, 00000435338BU9 082416050001, 00000395213BU2 082416070001, 00000418289BU5 082416070002, 00000561292BU4 082416070003, 00000395516BU8 082416100004, 00000418210BU1 082416100005, 00000388258BU6 082416120001, 00000418238BU2 082416120002, 00000429841BU0 082416120003, 00000435004BU7 082416120004, 00000349892BU0 082416130005, 00000393734BU9 082416130006, 00000411199BU3 082416130008, 00000421695BU8 082416130009, 00000349889BU6 082416140001, 00000446686BU8 082416160004, 00000446999BU5 082416200006, 00000388606BU6 082416210001, 00000424501BU5 082416210002, 00000464431BU6 082416210005, 00000424700BU3 082416220005, 00000418277BU0 082416220007, 00000387191BU0 082416250001, 00000433754BU9 082416250003, 00000397408BU6 082416270001, 00000466823BU2 082416310004, 00000472308BU6 082416310005, 00000473100BU6 082416010005, 00000537030BU9 082416010007, 00000559116BU9 082416010008, 00000572428BU1 082416020006, 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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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