—#140304

Product

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082318, K121387
Affected lot / code info: GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1

Why it was recalled

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

Root cause (FDA determination)

Software Design Change

Action the firm took

The firm, GE Healthcare, an "Urgent Medical Device Correction" by mail or hand delivered to all sites. The letter instructs the customer to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. Until GE Healthcare conducts remote inspection of the systems "MapRoute" parameter value. If the value is found to be greater than the recommended setting of 1, GE will reset this system parameter to a value of 1. The letter informs the user facilities not to make any changes to this parameter value. Additionally, until a product modification is available to correct this issue, the following actions are recommended. The firm is recommending user facilities to: 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the PACS IW viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, contact your GE Healthcare Service representative for assistance and instructions as to the impacted exam. Urgent cases impacted by this issue should be interpreted at the modality. 2. If DICOM storage commit is configured and in use, no commit notification is sent to the modality for images that were impacted by this issue. GE Healthcare will correct all affected systems by providing a software update at no cost to the user facilities. If the user facilities have questions, they are encouraged to communicate questions or concerns regarding this notification to GE Healthcare Service at 1-800-437-1171 or their local Service Representative.

Recalling firm

Firm: GE Healthcare
Address: 540 W Northwest Hwy, Barrington, Illinois 60010-3051

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) including states of: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and countries of: Argentina , Austria, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile , China, Colombia, Costa Rica, Ecuador, Egypt, France, Germany, Great Britain, Hong Kong, Hungary, India, Israel, Italy, Japan,Korea, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Nigeria, Panam¿, Peru, Philippines, Poland, Qatar, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, Venezuela, and Vietnam.

Timeline

Recall initiated: 2015-09-16
Posted by FDA: 2015-10-05
Terminated: 2017-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.