Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional…

Date

June 11, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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

Distribution pattern

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.

Quantity

3221 (108 US, 3113 OUS).

Codes and lots

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DZ1130VA01 00000614763BU1 DZ1209VA01 00000000001332 DZ1351VA01 0000010C2M0363 DZ1399VA01 FMI12209DUMM26 DZ1415VA01 FMI12209DUMM39 DZ1483VA01 FMI12209DUMM57 DZ1192VA01 FMI12209DUMM58 DZ1503VA01 FMI12209DUMM93 DZ1061VA01 00000579051BU4 DZ1027VA02 0000000DUMMY12 DZ1060VA01 00000434301BU8 DZ1027VA01 FMI12209DUMM159 DZ1050VA02 UNK2335139-603 AO1001VA01 FMI12198DUM024 2652ADVXLC 00000309014WK9 612576ADVX 000000TLK-3881 51230ADVLCX 00000580866BU2 341INV21 00000566829BU8 2722INV31 00000467850BU4 378INV31 00000557464BU5 4127INV31 00000570106BU5 4959INV31 00000011826BU5 512806ADVN 00000368409WK9 6124ADVCFM 00000252139BU1 1322875LCV 00000513495WK2 17883ADVLC 00000289992BU0 49638ADVXPF 00000506777WK2 0910062022 00000415812BU7 0910162004A 00000472994BU3 0910162009 00000447936BU6 0910163008 00000330900BU2 0910165002 00000569799BU0 0910064010 00000490794BU5 0910162010 00000494960BU8 0910162011 00000539718BU7 0910162012 00000547032BU3 0910162013 00000557687BU1 0910162014 00000464419BU1 0910163011 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00000549263BU2 082416230002 00000566597BU1 082416230003…

Recall started

May 2, 2014

Device type

Shield, Protective, Personnel

Root cause (FDA)

Equipment maintenance

What the company told customers

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. .

Recall number

Z-1706-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1706-2014. The agency record governs; check it and the company before acting.