Kenex Radiation Shield installed with GE Healthcare Interventional…

Date

April 22, 2015

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

Product

Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

Reason

GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.

Distribution pattern

Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.

Quantity

797 (3 US, 794 OUS).

Codes and lots

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00000593473BU2 FI1126VA02 00000600318BU0 FI1023VA03 00000000001585 M86323601 00000000LS8-C1 R4211476 00000006443GP6 M4196634 00000011C2A003 A4185526 0000008C2M0006 M9162723 0000009C2M0054 M4198062 00000403124BU1 A4213138 00000420032BU5 M2030707 00000428406BU3 S4160056 00000467451BU1 M2844529 00000477885BU8 M4163030 00000509548BU4 X1347902 00000516767BU1 B1650215 00000530416BU7 M4496941 00000534726BU5 M4183841 00000577527BU5 M4202928 00000581570BU9 A4199383 00000583669BU7 M2812105 00000585910BU3 M4161021 00000589023BU1 A4498251 00000589025BU6 A4498248 00000590863BU7 M1327508 00000592451BU9 X76305707 00000600858BU5 M4212443 00000605184BU1 M4169342 00000609125BU0 A9190167 00000614537BU9 M4040085 00000614683BU1 M4152252 00000615923BU0 M1524103 00000624849BU6 M40330122 00000628834BU4 M5484994 00000629344BU3 X1347901 00000017539YC8 M199701601 00000129709BT2 M4176111 0000011C2M0011 HC0220XR10 00000450631BU7 HC5533XR08 00000593057BU3 HC3260XR04 00000611304BU7 PC3006XR03 00000618174BU7 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Recall started

March 9, 2015

Device type

Shield, Protective, Personnel

Root cause (FDA)

Equipment maintenance

What the company told customers

GE Healthcare sent an Urgent Medical Device Correction letter dated March 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA contact 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative.

Recall number

Z-1441-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1441-2015. The agency record governs; check it and the company before acting.