Z-0023-2016Class II

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images...

Name: Z-0023-2016 Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images...
Creator: GE Healthcare
Published: 2015-09-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2015-09-16 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging... on 2015-09-16. FDA classified it as Class II and gives the reason as "Images may be missing when a system parameter MapRoute is set to a value greater than 1". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0023-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-16
Posted: 2015-10-05
Terminated: 2017-01-05
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Images may be missing when a system parameter MapRoute is set to a value greater than 1.
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 921 systems are impacted.
Distribution: 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.
Product codes and lots: GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0023-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0023-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-05

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)