Recall of Device Recall GE Healthcare Centricity PACSIW

Recall

79537

Class 2

Z-1302-2018

2018-02-23

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162605

A database handling error could occur during the image acquisition process affecting the completeness of acquired images with centricity pacs-iw. there is a potential that one or more image series (i.E. all images within an image set) may be missing from an exam without indication to the user. while this is rare, this can occur with imaging studies that consist of a very small number of images per series. e.G. cr thorax exam with 1 image per series.

GE Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2018 to their customers. The letter provided the affected product, problem and provided the following safety instructions: "Until a product modification is available to correct this issue, the following actions are recommended: 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 Universal Viewer. a. If a discrepancy is identified, attempt to retransmit the exam to PACS. b. If retransmission is unsuccessful, a GE Healthcare Service representative will need to be contacted to assist with resolution of 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. 3. Attention should be given to prior cases, acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue." If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.