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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67136

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 07, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.

Z-0725-2014
Recall number
Z-0725-2014
Initiated
November 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
1027

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx Mobile X-ray Systems. Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams when displayed on the mobile x-ray system are not properly displayed. If the user continues to attempt to select one of the exams w

Code information

Serial Numbers: 00000002796EN1, 00000002797EN9, 00000002798EN7, 00000002799EN5, 00000002800EN1, 00000002801EN9, 00000102726WK9, 00000102789WK3, 00000102937WK7, 00000130778WK3, 00000UA45526-8, 00001027058WK5, 00001027061WK9, 00001027146WK8, 00001027149WK2, 00001027150WK0, 00001027151WK8, 00001027153WK4, 00001027154WK2, 00001027167WK4, 00001027168WK2, 00001027169WK0, 00001027175WK7, 00001027193WK0, 00001027194WK8, 00001027195WK5, 00001027199WK7, 00001027200WK3, 00001027203WK7, 00001027204WK5, 00001027207WK8, 00001027214WK4, 00001027256WK5, 00001027259WK9, 00001027260WK7, 00001027262WK3, 00001027264WK9, 00001027265WK6, 00001027267WK2, 00001027268WK0, 00001027269WK8, 00001027276WK3, 00001027277WK1, 00001027278WK9, 00001027280WK5, 00001027293WK8, 00001027294WK6, 00001027295WK3, 00001027297WK9, 00001027298WK7, 00001027299WK5, 00001027300WK1, 00001027301WK9, 00001027302WK7, 00001027303WK5, 00001027314WK2, 00001027318WK3, 00001027322WK5, 00001027323WK3, 00001027324WK1, 00001027325WK8, 00001027326WK6, 00001027344WK9, 00001027346WK4, 00001027347WK2, 00001027349WK8, 00001027350WK6, 00001027351WK4, 00001027352WK2, 00001027353WK0, 00001027354WK8, 00001027356WK3, 00001027359WK7, 00001027362WK1, 00001027363WK9, 00001027364WK7, 00001027369WK6, 00001027371WK2, 00001027372WK0, 00001027373WK8, 00001027374WK6, 00001027376WK1, 00001027377WK9, 00001027380WK3, 00001027382WK9, 00001027383WK7, 00001027384WK5, 00001027386WK0, 00001027387WK8, 00001027388WK6, 00001027389WK4, 00001027390WK2, 00001027406WK6, 00001027407WK4, 00001027416WK5, 00001027417WK3, 00001027418WK1, 00001027421WK5, 00001027422WK3, 00001027423WK1, 00001027438WK9, 00001027445WK4, 00001027450WK4, 00001027451WK2, 00001027452WK0, 00001027464WK5, 00001027465WK2, 00001027466WK0, 00001027487WK6, 00001027488WK4, 00001027489WK2, 00001027490WK0, 00001027506WK3, 00001027507WK1, 00001027508WK9, 00001027539WK4, 00001027540WK2, 00001027541WK0, 00001027542WK8, 00001027543WK6, 00001027544WK4, 00001027551WK9, 00001027552WK7, 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00001028353WK9, 00001028354WK7, 00001028363WK8, 00001028365WK3, 00001028369WK5, 00001028370WK3, 00001028396WK8, 00001028397WK6, 00001028398WK4, 00001028399WK2, 00001028464WK4, 00001028465WK1, 00001028467WK7, 00001028468WK5, 00001028469WK3, 00001028470WK1, 00001028471WK9, 00001028472WK7, 00001028476WK8, 00001028477WK6, 00001028478WK4, 00001028501WK3, 00001028502WK1, 00001028503WK9, 00001028505WK4, 00001028506WK2, 00001028517WK9, 00001028518WK7, 00001028519WK5, 00001028520WK3, 00001028522WK9, 00001028523WK7, 00001028524WK5, 00001028536WK9, 00001028537WK7, 00001028538WK5, 00001028539WK3, 00001028559WK1, 00001028560WK9, 00001028561WK7, 00001028562WK5, 00001028563WK3, 00001028574WK0, 00001028575WK7, 00001028576WK5, 00001028605WK2, 00001028617WK7, 00001028621WK9, 00001028680WK5, 00001028681WK3, 00001028682WK1, 00001028683WK9, 00001028685WK4, 00001028686WK2, 00001028687WK0, 00001028688WK8, 00001028689WK6, 00001028690WK4, 00001028691WK2, 00001028692WK0, 00001028693WK8, 00001028694WK6, 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00001029595WK4, 00001029597WK0, 00001029598WK8, 00001029614WK3, 00001029615WK0, 00001029616WK8, 00001029620WK0, 00001029621WK8, 00001029622WK6, 00001029625WK9, 00001029626WK7, 00001029628WK3, 00001029630WK9, 00001029631WK7, 00001029632WK5, 00001029635WK8, 00001029636WK6, 00001029639WK0, 00001029640WK8, 00001029641WK6, 00001029642WK4, 00001029643WK2, 00001029649WK9, 00001029650WK7, 00001029651WK5, 00001029652WK3, 00001029653WK1, 00001029654WK9, 00001029655WK6, 00001029656WK4, 00001029657WK2, 00001029658WK0, 00001029674WK7, 00001029675WK4, 00001029676WK2, 00001029677WK0, 00001029678WK8, 00001029679WK6, 00001029681WK2, 00001029683WK8, 00001029684WK6, 00001029685WK3, 00001029693WK7, 00001029694WK5, 00001029695WK2, 00001029696WK0, 00001029697WK8, 00001029698WK6, 00001029699WK4, 00001029700WK0, 00001029701WK8, 00001029702WK6, 00001029724WK0, 00001029725WK7, 00001029726WK5, 00001029727WK3, 00001029728WK1, 00001029729WK9, 00001029733WK1, 00001029734WK9, 00001029735WK6, 00001029736WK4, 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00001030273WK5, 00001030284WK2, 00001030285WK9, 00001030286WK7, 00001030287WK5, 00001030288WK3, 00001030289WK1, 00001030290WK9, 00001030291WK7, 00001030292WK5, 00001030293WK3, 00001030366WK7, 00001030367WK5, 00001030368WK3, 00001030369WK1, 00001030371WK7, 00001030406WK1, 00001030407WK9, 00001030408WK7, 00001030432WK7, 00001030433WK5, 00001030437WK6, 00001030438WK4, 00001030510WK0, 00001030511WK8, 00001030512WK6, 00001030513WK4, 00001030514WK2, 00001030531WK6, 00001030532WK4, 00001030533WK2, 00001030534WK0, 00001030535WK7, 00001030536WK5, 00001030537WK3, 00001030538WK1, 00001030539WK9, 00001030540WK7, 00001030557WK1, 00001030558WK9, 00001030559WK7, 00001030560WK5, 00001030561WK3, 00001030562WK1, 00001030585WK2, 00001030586WK0, 00001030587WK8, 00001030588WK6, 00001030589WK4, 00001030590WK2, 00001030591WK0, 00001030592WK8, 00001030593WK6, 00001030594WK4, 00001030595WK1, 00001030596WK9, 00001030597WK7, 00001030598WK5, 00001030602WK5, 00001030603WK3, 00001030604WK1, 00001030605WK8, 00001030606WK6, 00001030607WK4, 00001030617WK3, 00001030618WK1, 00001030619WK9, 00001030627WK2, 00001030628WK0, 00001030636WK3, 00001030637WK1, 00001030638WK9, 00001030654WK6, 00001030655WK3, 00001030656WK1, 00001030657WK9, 00001030660WK3, 00001030661WK1, 00001030669WK4, 00001030671WK0, 00001030672WK8, 00001030673WK6, 00001030674WK4, 00001030675WK1, 00001030736WK1, 00001030737WK9, 00001030738WK7, 00001030743WK7, 00001030744WK5, 00001030759WK3, 00001030760WK1, 00001030761WK9, 00001030762WK7, 00001030763WK5, 00001030775WK9, 00001030776WK7, 00001030777WK5, 00001030778WK3, 00001030779WK1, 00001030780WK9, 00001030781WK7, 00001030782WK5, 00001030791WK6, 00001030792WK4, 00001030793WK2, 00001030794WK0, 00001030795WK7, 00001030796WK5, 00001030797WK3, 00001030799WK9, 00001030800WK5, 00001030801WK3, 00001030802WK1, 00001030803WK9, 00001030804WK7, 00001030805WK4, 00001030806WK2, 00001030807WK0, 00001030808WK8, 00001030809WK6, 00001030810WK4, 00001030811WK2, 00001030812WK0, 00001030813WK8, 00001030814WK6, 00001030815WK3, 00001030816WK1, 00001030839WK3, 00001030840WK1, 00001030841WK9, 00001030842WK7, 00001030843WK5, 00001030844WK3, 00001030845WK0, 00001030846WK8, 00001030847WK6, 00001030849WK2, 00001030850WK0, 00001030854WK2, 00001030856WK7, 00001030899WK7, 00001030900WK3, 00001030901WK1, 00001030903WK7, 00001030904WK5, 00001030905WK2, 00001030907WK8, 00001030908WK6, 00001030909WK4, 00001030915WK1, 00001030916WK9, 00001030917WK7, 00001030918WK5, 00001030919WK3, 00001030920WK1, 00001030921WK9, 00001030922WK7, 00001030925WK0, 00001030926WK8, 00001030928WK4, 00001030929WK2, 00001030930WK0, 00001030950WK8, 00001030951WK6, 00001030952WK4, 00001030953WK2, 00001030954WK0, 00001030955WK7, 00001030956WK5, 00001030957WK3, 00001030958WK1, 00001030959WK9, 00001030960WK7, 00001030962WK3, 00001030963WK1, 00001030964WK9, 00001030993WK8, 00001030994WK6, 00001030995WK3, 00001031006WK8, 00001031007WK6, 00001031008WK4, 00001031009WK2, 00001031010WK0, 00001031011WK8, 00001031012WK6, 00001031013WK4, 00001031014WK2, 00001031017WK5, 00001031018WK3, 00001031019WK1, 00001031020WK9, 00001031021WK7, 00001031028WK2, 00001031029WK0, 00001031031WK6, 00001031032WK4, 00001031033WK2, 00001031053WK0, 00001031054WK8, 00001031055WK5, 00001031058WK9, 00001031059WK7, 00001031060WK5, 00001031061WK3, 00001031062WK1, 00001031063WK9, 00001031064WK7, 00001031108WK2, 00001031109WK0, 00001031110WK8, 00001031111WK6, 00001031112WK4, 00001031113WK2, 00001031116WK5, 00001031117WK3, 00001031118WK1, 00001031119WK9, 00001031120WK7, 00001031121WK5, 00001031122WK3, 00001031123WK1, 00001031124WK9, 00001031125WK6, 00001031153WK8, 00001031154WK6, 00001031155WK3, 00001031156WK1, 00001031157WK9, 00001031158WK7, 00001031166WK0, 00001031167WK8, 00001031168WK6, 00001031169WK4, 00001031170WK2, 00001031172WK8, 00001031173WK6, 00001031174WK4, 00001031175WK1, 00001031176WK9, 00001031177WK7, 00001031178WK5, 00001031179WK3, 00001031181WK9, 00001031206WK4, 00001031207WK2, 00001031208WK0, 00001031213WK0, 00001031214WK8, 00001031215WK5, 00001031215WK5, 00001031216WK3, 00001031219WK7, 00001031220WK5, 00001031221WK3, 00001031222WK1, 00001031226WK2, 00001031227WK0, 00001031228WK8, 00001031229WK6, 00001031235WK3, 00001031238WK7, 00001031239WK5, 00001031246WK0, 00001031247WK8, 00001031248WK6, 00001031249WK4, 00001031250WK2, 00001031251WK0, 00001031281WK7, 00001031282WK5, 00001031283WK3, 00001031284WK1, 00001031286WK6, 00001031287WK4, 00001031332WK8, 00001031334WK4, 00001031335WK1, 00001031336WK9, 00001031337WK7, 00001031338WK5, 00001031339WK3, 00001031341WK9, 00001031342WK7, 00001031343WK5, 00001031350WK0, 00001031351WK8, 00001031352WK6, 00001031353WK4, 00001031361WK7, 00001031362WK5, 00001031363WK3, 00001031386WK4, 00001031387WK2, 00001031389WK8, 00001031390WK6, 00001031391WK4, 00001031392WK2, 00001031401WK1, 00001031402WK9, 00001031403WK7, 00001031408WK6, 00001031413WK6, 00001031414WK4, 00001031415WK1, 00001031416WK9, 00001031457WK3, 00001031458WK1, 00001031459WK9, 00001031460WK7, 00001031461WK5, 00001031462WK3, 00001031464WK9, 00001031465WK6, 00001031466WK4, 00001031467WK2, 00001031468WK0, 00001031479WK7, 00001031480WK5, 00001031481WK3, 00001031483WK9, 00001031484WK7, 00001031490WK4, 00001031491WK2, 00001031492WK0, 00001031493WK8, 00001031495WK3, 00001031496WK1, 00001031506WK7, 00001031507WK5, 00001031508WK3, 00001031510WK9, 00001031511WK7, 00001031512WK5, 00001031515WK8, 00001031516WK6, 00001031517WK4, 00001031518WK2, 00001031519WK0, 00001031520WK8, 00001031521WK6, 00001031522WK4, 00001031523WK2, 00001031524WK0, 00001031525WK7, 00001031537WK2, 00001031538WK0, 00001031539WK8, 00001031566WK1, 00001031567WK9, 00001031568WK7, 00001031569WK5, 00001031570WK3, 00001031571WK1, 00001031572WK9, 00001031573WK7, 00001031574WK5, 00001031581WK0, 00001031649WK5, 00001031650WK3, 00001031651WK1, 00001031652WK9, 00001031653WK7, 00001031654WK5, 00001031655WK2, 00001031656WK0, 00001031657WK8, 00001031658WK6, 00001031659WK4, 00001031660WK2, 00001031661WK0, 00001031662WK8, 00001031665WK1, 00001031666WK9, 00001031667WK7, 00001031669WK3, 00001031670WK1, 00001031671WK9, 00001031672WK7, 00001031673WK5, 00001031674WK3, 00001031675WK0, 00001031676WK8, 00001031677WK6, 00001031699WK0, 00001031700WK6, 00001031702WK2, 00001031703WK0, 00001031704WK8, 00001031705WK5, 00001031706WK3, 00001031711WK3, 00001031712WK1, 00001031728WK7, 00001031729WK5, 00001031730WK3, 00001031733WK7, 00001031734WK5, 00001031735WK2, 00001031738WK6, 00001031739WK4, 00001031740WK2, 00001031749WK3, 00001031750WK1, 00001031751WK9, 00001031752WK7, 00001031810WK3, 00010299771WK7.

Distribution pattern

Worldwide Distribution-USA (nationwide) including Washington D.C., and Guam and the countries of ALBANIA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA , COLOMBIA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAQ, IRELAND, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, NIGERIA, NORWAY, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.