Recall Z-0118-2014— Ge Healthcare It

Name: FDA recall Z-0118-2014
Creator: U.S. Food and Drug Administration
Published: 2012-06-15

Class II · Terminated

Class II FDA medical device recall by Ge Healthcare It, initiated 2012-06-15, terminated 2016-06-10. It names one FDA 510(k) clearance: K083018. 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. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.. Reason: Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe.

Recalling firm: Ge Healthcare It
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Terminated: 2016-06-10
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K083018 — CENTRICITY PACS WEB DIAGNOSTICGe Healthcare Dynamic Imaging Solutions·cleared 2008-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

Reason for recall

Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe

Data sourced from openFDA. This site is unofficial and independent of the FDA.