FDA · Medical device recall

GE Precision 500D… and 1 more product

Sept. 19, 2008

Date posted by the FDA: Sept. 19, 2008
Status: Terminated
Filed by: GE Healthcare
Reason: GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image I
Distribution pattern: Nationwide, Washington D.C. and Puerto Rico and OUS to include: ARGENTINA, AUSTRALIA, BRAZIL, CANADA, CHILE, DOMINICAN REPUBLIC, EGYPT, GERMANY, HONDURAS, INDIA, INDONESIA, IRELAND, JAMAICA, KOREA, KUWAIT, MALAYSIA, MEXICO, NETHERLANDS, PANAMA, RUSSIAN FEDERATION, SAUDIA ARABIA, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM,

2 products in this recall

GE Precision 500D…

Product: GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
Quantity: 2863 total (2744 US / 119 OUS)
Codes and lots: serial numbers: 00000004108GQ7, 00000004874GQ4, 00000006742GQ1, 00000007111GQ8, 00000008717GQ1, 00000008892GP2, 00000010136GQ0, 00000012808GP2, 00000013547GP5, 00000013737GP2, 00000013844GP6, 00000985953WK9, 00000987224WK3, 00000987333WK2, 00000989376WK9, 00012966GP8000, 00000000BRBGDM, 00000000BRBGDR, 00000000BRBUF8, 00000000BRD138, 00000000BRF490, 00000000BRF49B, 00000000BRBBXV, 00000000BRBL7V, 00000000BRETRE, 00000986515WK5, 00000097958WK2, 000000980212WK, 00000098186WK0, 00000098235WK4, 00000098734WK5, 00000970756WK3, 00000971704WK2, 00000972504WK5, 00000972505WK2, 00000972772WK8, 00000973070WK6, 00000973500WK2, 00000973502WK8, 00000973616WK6, 00000973617WK4, 00000973618WK2, 00000973624WK0, 00000973883WK2, 00000973884WK0, 00000973885WK7, 00000974085WK3, 00000974087WK9, 00000974410WK3, 00000974411WK1, 00000974412WK9, 00000974445WK9, 00000974446WK7, 00000974447WK5, 00000974676WK9, 00000974677WK7, 00000974678WK5, 00000975166WK0, 00000975167WK8, 00000975169WK4, 00000975171WK0, 00000975172WK8, 00000975626WK3, 00000975627WK1, 00000975628WK9, 00000975629WK7, 00000975630WK5, 00000975631WK3, 00000975632WK1, 00000975946WK5, 00000975947WK3, 00000975948WK1, 00000975949WK9, 00000975958WK0, 00000975959WK8, 00000975960WK6, 00000975961WK4, 00000975962WK2, 00000975964WK8, 00000977046WK2, 00000977047WK0, 00000977048WK8, 00000977049WK6, 00000977050WK4, 00000977051WK2, 00000977052WK0, 00000977053WK8, 00000977054WK6, 00000977055WK3, 00000977233WK6, 00000977234WK4, 00000977236WK9, 00000977238WK5, 00000977239WK3, 00000977853WK1, 00000977854WK9, 00000977855WK6, 00000977857WK2, 00000977858WK0, 00000977859WK8, 00000977860WK6, 00000977861WK4, 00000978079WK2, 00000978080WK0, 00000978082WK6, 00000978083WK4, 00000978084WK2, 00000978085WK9, 00000978086WK7, 00000978485WK1, 00000978486WK9, 00000978487WK7, 00000978488WK5, 00000978489WK3, 00000978490WK1, 00000978491WK9, 00000978492WK7, 00000978493WK5, 00000978494WK3, 00000978715WK1, 00000978716WK9, 00000978826WK6, 00000978827WK4, 00000979056WK9, 00000979057WK7, 00000979083WK3, 00000979084WK1, 00000979097WK3, 00000979125WK2, 00000979126WK0, 00000979150WK0, 00000979151WK8, 00000979206WK0, 00000979207WK8, 00000979227WK6, 00000979228WK4, 00000979256WK5, 00000979257WK3, 00000979380WK3, 00000979381WK1, 00000979388WK6, 00000979389WK4, 00000979390WK2, 00000979391WK0, 00000979448WK8, 00000979449WK6, 00000979450WK4, 00000979466WK0, 00000979467WK8, 00000979468WK6, 00000979469WK4, 00000979516WK2, 00000979517WK0, 00000979518WK8, 00000979584WK0, 00000979638WK4, 00000979639WK2, 00000979640WK0, 00000979641WK8, 00000979691WK3, 00000979692WK1, 00000979693WK9, 00000979827WK3, 00000979828WK1, 00000979894WK3, 00000979895WK0, 00000979896WK8, 00000979897WK6, 00000979898WK4, 00000979941WK2, 00000979942WK0, 00000979944WK6, 00000979945WK3, 00000980041WK8, 00000980042WK6, 00000980043WK4, 00000980044WK2, 00000980045WK9, 00000980183WK8, 00000980213WK3, 00000980317WK2, 00000980318WK0, 00000980319WK8, 00000980321WK4, 0000098032OWK6, 00000980423WK8…
Recall started: Jan. 2, 2008
Device type: System, X-Ray, Fluoroscopic, Image-Intensified
Root cause (FDA): Nonconforming Material/Component
What the company told customers: A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.
Recall number: Z-1610-2008

Advantx Legacy Radiographic and Fluoroscopic systems…

Product: Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
Quantity: 2863 total (2744 US / 119 OUS)
Codes and lots: serial numbers: 000000000BH563, 00000004777GP9, 00000005003GP9, 00000014648GP0, 00000046998VP1, 00000048828VP8, 00000054168VP0, 00000054198VP7, 00000062777ES8, 00000062779ES4, 00000062797ES6, 00000062797VP6, 00000062813VP1, 00000062839ES6, 00000065436VP8, 00000066102DP5, 00000066138DP9, 00000076156MA9, 00000077242DP6, 00000077245DP9, 00000077246DP7, 00000077348MA1, 00000080468MA2, 00000084227VP8, 00000095705VP0, 00000097498WK1, 000000T7113MA8, 00000419764BU6, 00000431324BU3, 00000491331WK5, 00000493021WK0, 00000493022WK8, 00000494787WK5, 00000495471WK5, 00000495922WK7, 00000495960WK7, 00000498299WK7, 00000498516WK4, 00000498844WK0, 00000499720WK1, 00000499789WK6, 00000499936WK3, 00000500252WK2, 00000500371WK0, 00000500420WK5, 00000500452WK8, 00000500631WK7, 00000500800WK8, 00000500961WK8, 00000501080WK6, 00000501165WK5, 00000501317WK2, 00000501405WK5, 00000501497WK2, 00000501624WK1, 00000501678WK7, 00000501690WK2, 00000501845WK2, 00000502382WK5, 00000502469WK0, 00000502656WK2, 00000502668WK7, 00000502673WK7, 00000502695WK0, 00000502802WK2, 00000503403WK8, 00000503589WK4, 00000503651WK2, 00000503720WK5, 00000503889WK8, 00000503918WK5, 00000504087WK8, 00000504160WK3, 00000504221WK3, 00000504364WK1, 00000504537WK2, 00000504561WK2, 00000504626WK3, 00000504708WK9, 00000504795WK6, 00000504902WK8, 00000504944WK0, 00000505067WK9, 00000505194WK1, 00000505213WK9, 00000505230WK3, 00000505232WK9, 00000505354WK1, 00000505451WK5, 00000505565WK2, 00000505950WK6, 00000505965WK4, 00000506038WK9, 00000506375WK5, 00000506408WK4, 00000506445WK6, 00000506488WK6, 00000506569WK3, 00000506570WK1, 00000506775WK6, 00000506799WK6, 00000506800WK2, 00000506963WK8, 00000507015WK6, 00000507025WK5, 00000507170WK9, 00000507237WK6, 00000507579WK1, 00000507580WK9, 00000507827WK4, 00000508212WK8, 00000508240WK9, 00000508339WK9, 00000508340WK7, 00000508460WK3, 00000508478WK5, 00000508509WK7, 00000508653WK3, 00000508686WK3, 00000509091WK5, 00000509092WK3, 00000509188WK9, 00000509194WK7, 00000509195WK4, 00000509202WK8, 00000509609WK4, 00000509806WK6, 00000509916WK3, 00000509991WK6, 00000510108WK4, 00000510319WK7, 00000510325WK4, 00000510326WK2, 00000510493WK0, 00000510518WK4, 00000510774WK3, 00000510873WK3, 00000510874WK1, 00000511384WK0, 00000511507WK6, 00000511508WK4, 00000511509WK2, 00000511689WK2, 00000511730WK4, 00000512111WK6, 00000512199WK1, 00000512413WK6, 00000512414WK4, 00000512415WK1, 00000512632WK1, 00000512850WK9, 00000512851WK7, 00000512852WK5, 00000513150WK3, 00000513151WK1, 00000513152WK9, 00000513796WK3, 00000513797WK1, 00000513819WK3, 00000514016WK5, 00000514026WK4, 00000514030WK6, 00000514185WK8, 00000514342WK5, 00000514425WK8, 00000514595WK8, 00000514833WK3, 00000514882WK0, 00000514883WK8, 00000514885WK3, 00000515060WK2, 00000515206WK1, 00000515334WK1, 00000515375WK4, 00000515401WK8, 00000515454WK7, 00000515707WK8, 00000515769WK8, 00000516111WK2, 00000516203WK7, 00000516228WK4, 00000516513WK9, 00000516514WK7, 00000516665WK7, 00000516955WK2, 00000516978WK4…
Recall started: Jan. 2, 2008
Device type: Table, Radiographic, Tilting
Root cause (FDA): Nonconforming Material/Component
What the company told customers: A Product Safety Notification letter, dated 01/09/2008 was sent to affected customers. This letter described the safety issue, affected product and safety instructions. A GE Field Engineer will schedule a field visit to affected customers to inspect and replace the park latch switch as needed.
Recall number: Z-1611-2008

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1610-2008, Z-1611-2008. The agency record governs; check it and the company before acting.

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