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U.S. Department of Health and Human Services

Class 2 Device Recall Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR Sy

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 Class 2 Device Recall Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR Sy see related information
Date Posted May 01, 2013
Recall Status1 Terminated on November 03, 2014
Recall Number Z-1209-2013
Recall Event ID 64918
510(K)Number K103330  K053009  K043112 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System.

Indicated for use as a diagnostic imaging device.
Code Information 5
242143HM6
269409HM9
229427HM0
261011HM1
265007HM5
267652HM6
261005HM3
250465HM2
257783HM1
276180HM7
293127HM7
266900HM0
185390HM2
259654HM2
293092HM3
187162HM3
250459HM5
267643HM5
293130HM1
280902HM8
283381HM2
245745HM5
257792HM2
196358HM6
265001HM8
252375HM1
261008HM7
245624HM2
269309HM1
267646HM8
257780HM7
293089HM9
193207HM8
252396HM7
295723HM1
296425HM2
297321HM2
297792HM4
298506HM7
298509HM1
298515HM8
305147HM1
306415HM1
307327HM7
307330HM1
307333HM5
305842HM7
182226HM1
187469HM2
188934HM4
254619HM0
291203HM8
305318HM8
306308HM8
188814HM8
265023HM2
189945HM9
256448HM2
259663HM3
305306HM3
291784HM7
204173HM9
289103HM4
261730HM6
300914HM9
181534HM9
221022HM7
217783HM0
192378HM8
280559HM6
208928HM2
193130HM2
177380HM3
305129HM9
247878HM2
198004HM4
198790HM8
224716HM1
245556HM6
274215HM3
280905HM1
281443HM2
309473HM7
197709HM9
259648HM4
223609HM9
264183HM5
281277HM4
224451HM5
249456HM5
196791HM8
216112HM3
235831HM5
259410HM9
245748HM9
185608HM7
214982HM1
230838HM5
263688HM4
256433HM4
262310HM6
268809HM1
168747HM4
194588HM0
202467HM7
278684HM6
281428HM3
286880HM0
299936HM5
300200HM3
167093HM4
241081HM9
284466HM0
229562HM4
262295HM9
259420HM8
252402HM3
276192HM2
261736HM3
264992HM9
175009HM0
176123HM8
176952HM0
194652HM4
206783HM3
210539HM3
213393HM2
224442HM4
226020HM6
230214HM9
293118HM6
294820HM6
266894HM5
266897HM8
271733HM8
281440HM8
291778HM9
281431HM7
263673HM6
261733HM0
182601HM5
200902HM5
205894HM9
226420HM8
226780HM5
252497HM3
297822HM9
252393HM4
256141HM3
257771HM6
257798HM9
207286HM6
264554HM7
286898HM2
286901HM4
212641HM5
236222HM6
256156HM1
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276207HM8
290033HM0
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264983HM8
175614HM7
206808HM8
264586HM9
262298HM3
207131HM4
284460HM3
250048HM6
259657HM5
190053HM9
298500HM0
252411HM4
197721HM4
214032HM5
264980HM4
286649HM9
198712HM2
204139HM0
295732HM2
165274HM2
289091HM1
183671HM7
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260996HM4
262286HM8
262289HM2
183345HM8
197244HM7
247882HM4
276204HM5
278687HM9
285902HM3
264986HM1
264998HM6
280556HM2
290036HM3
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297819HM5
300197HM1
250057HM7
184795HM3
270513HM5
271706HM4
295729HM8
297324HM6
252408HM0
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293121HM0
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276210HM2
278672HM1
281425HM9
284463HM7
285911HM4
289096HM0
297306HM3
297327HM9
242138HM6
223718HM8
263691HM8
228528HM6
256153HM8
282413HM4
292521HM2
300203HM7
301816HM5
301819HM9
302734HM9
302737HM2
305153HM9
305156HM2
308177HM5
308929HM9
309506HM4
309509HM8
310727HM3
311241HM4
312231HM4
312379HM1
194662HM3
223449HM0
264205HM6
276198HM9
171699HM2
269456HM0
291215HM2
278675HM4
266903HM4
266906HM7
278678HM8
267634HM4
281422HM6
263685HM0
268812HM5
264989HM5
269447HM9
274224HM5
199733HM7
181103HM3
180699HM1
171698HM4
229582HM2
224689HM0
293124HM4
302716HM6
270510HM1
243170HM8
196395HM8
290030HM6
199942HM4
290024HM9
227474HM4
241065HM2
265034HM9
222113HM3
210288HM7
193196HM3
297801HM3
257843HM3
240130HM5
170081HM4
227429HM8
235191HM4
309470HM3
256144HM7
273789HM8
257546HM2
226814HM2
262319HM7
214907HM8
172794HM0
198684HM3
241050HM4
172560HM5
239726HM3
262304HM9
281416HM8
291206HM1
291209HM5
292527HM9
293083HM2
293086HM5
293133HM5
293806HM6
294367HM8
294370HM2
294814HM9
294817HM2
308912HM5
308926HM5
309479HM4
309482HM8
309491HM9
309494HM3
309497HM6
309500HM7
309503HM1
310697HM8
310700HM0
310703HM4
310706HM7
310709HM1
310712HM5
310715HM8
310718HM2
310721HM6
310724HM0
311119HM2
311122HM6
311125HM9
312210HM8
312213HM2
312216HM5
312219HM9
312222HM3
312225HM6
312228HM0
312349HM4
312352HM8
312355HM1
312358HM5
312361HM9
312364HM3
312367HM6
199950HM7
205562HM2
171317HM1
236450HM3
271730HM4
297309HM7
252405HM6
256430HM0
256455HM7
250045HM2
257786HM4
25
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1, BRAVO T1, or CUBE T1) of over 126 slices may display a left-to-right image flip . In addition, the acquired sagittal images may be annotated with left-right location annotation revers
FDA Determined
Cause 2
Software design
Action GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Quantity in Commerce 864 (57 US; 802 OUS)
Distribution Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, excluding the state of RI and the countries of Yugoslavia YEMEN Viet Nam Venezuela Uzbekistan Uruguay United Arab Emirates Tunisia Thailand Tanzania Taiwan Turkey Syria Switzerland Sweden Spain South Korea South Africa Slovenia Slovakia Singapore Saudi Arabia Russia Romania Reunion Qatar Portugal Poland Philippines Peru Pakistan Paraguay Philippines Oman Norway Nigeria New Zealand Netherlands Morocco Mexico Martinique Malaysia Macedonia Mauritania Luxembourg Lithuania Libya Lebanon Latvia Kuwait Kenya Korea Korea (Republic Of [South] Korea) KUWAIT Kazakhstan Jordan Japan Jamaica Italy Israel Ireland Iran Iraq Indonesia India Hungary Hong Kong Honduras Guadeloupe Greece Germany Georgia, Republic of French Polynesia France Finland Estonia Ecuador Egypt Denmark Dominican Republic Czech Republic Croatia Colombia China Chile Canada Bulgaria Brazil Bosnia And Herzegovina Belgium Belarus Barbados Bahrain Austria Australia Argentina Arab Emirates Algeria and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE HANGWEI MEDICAL SYSTEMS CO., LTD.
510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = LNH and Original Applicant = GENERAL ELECTRIC CO.
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