510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0725-2014Class II

GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers...

GE Healthcare / initiated 2013-11-07 / Terminated / root cause: software
FDA source (opens on fda.gov)

GE Healthcare, LLC began a recall of GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0725-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Product code
IZL System, X-Ray, Mobile
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
Root cause tag
software
FDA root cause
Software design
Action
GE sent an Urgent Medical Device Correction letter, dated 11/7/2013 to consignees. The letter described the issue, identified devices affected and stated that users should pay close attention to the patient exam/entry selected from the worklist prior to selecting the Start Exam button to ensure that the system did not update and select an incorrect exam. The user may also confirm during the exam that the appropriate patient information was selected via the display on the upper left portion. GE will fix the units with a software fix at no cost.
Quantity in commerce
1027
Distribution
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.
Product codes and lots
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, 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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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0725-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0725-2014Class IITerminatedVoluntary: Firm initiated