Z-0212-2014Class II

Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system...

Name: Z-0212-2014 Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system...
Creator: Carestream Health Inc.
Published: 2013-09-16
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-09-16 / Terminated / root cause: software

FDA source

Carestream Health Inc. began a recall of Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable... on 2013-09-16. FDA classified it as Class II and gives the reason as "Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer...". 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-0212-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-11-13
Terminated: 2015-12-21
Recalling firm: Eastman Kodak Company
Product: Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.
Root cause tag: software
FDA root cause: Software design
Action: Carestream sent an Urgent Medical Device Recall letter dated September 13, 2013, to all affected customers via Fed Ex on September 16, 2013, informing them that a software problem may have the potential to occur under certain conditions when using the CARESTREAM Client Workstation. When certain conditions are met, it appears that the child background process completes its tasks before the parent process and as a result the parent process considers its work done and terminates. In the event that a software problem does occur, the scan may not be fluent or the image numbers may not be sequential. A software patch is currently being deployed by Carestream Health. Customers were instructed that they would be contacted by a Carestream Service Engineer to coordinate the deployment. Customers with questions were instructed to call 1-866 737 2487 or they may call the Carestream Customer Care Center at 1-800-328-2910, 8AM through 8pm Eastern Standard Time. For questions regarding this recall call 1-800-328-2910.
Distribution: Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, IA, IL, MA, MD, ME, MN, MO, NC, NH, NV, NY, OH, OK, PA, RI, TN, UT, VA WA, and WI and Internationally to Canada, Japan, and Kuwait.
Product codes and lots: Model: Vue PACS client version 11.3.2.0 / 11.3.2.4 / 11.4 Catalog Number: 1013226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0212-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0211-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0212-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0213-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0214-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0215-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0216-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0217-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0218-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0219-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0220-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0221-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0222-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0223-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0224-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0225-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0226-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0227-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0228-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0229-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0230-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0231-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0232-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0233-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0234-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0235-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0236-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0237-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0238-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0239-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0240-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0241-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0242-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0243-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0244-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0245-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0246-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0247-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0248-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0249-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0250-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0251-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0252-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0253-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0254-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0255-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0256-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0257-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0258-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0259-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13
Z-0260-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code LLZ

K110919Class IICarestream PacsCarestream Health, Inc. / cleared 2011-10-20

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)