Z-2300-2016Class II

Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18

Name: Z-2300-2016 Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18
Creator: Ge Healthcare It
Published: 2013-02-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-02-18 / Terminated / root cause: software

FDA source

Ge Healthcare It began a recall of Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained... on 2013-02-18. FDA classified it as Class II and gives the reason as "A software defect was discovered that causes images to be out of context with clinical information". 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-2300-2016
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Posted: 2016-07-28
Terminated: 2017-12-13
Recalling firm: GE Healthcare
Product: Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software defect was discovered that causes images to be out of context with clinical information.
Root cause tag: software
FDA root cause: Software design
Action: GE sent an "Urgent Medical Device Correction" letter to all affected customers on April 2, 2013.The letter identified the product the problem and the action customers need to take. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #85204. For further questions, please call ( 847) 277-4468.
Quantity in commerce: 13
Distribution: US Nationwide Distribution.
Product codes and lots: Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2300-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2300-2016	Class II	Terminated	N/A	2016-08-03	2016-07-28

Product code LLZ

K052618Class IIImagecast PacsIdx Systems Corp. / cleared 2005-11-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)