Z-1243-2007

Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities

Name: Z-1243-2007 Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities
Creator: Cerner Corp
Published: 2007-08-23
License: https://open.fda.gov/license/

Cerner Corporation / initiated 2007-08-23 / Terminated / root cause: software

FDA source

Cerner Corp began a recall of Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities on 2007-08-23. The reason FDA records is "Defects in the Auto Launch functionality make it possible for a mismatch of patient data". 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-1243-2007
Status: Terminated
Initiated: 2007-08-23
Posted: 2007-09-25
Terminated: 2007-11-29
Recalling firm: Cerner Corporation
Product: Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Defects in the Auto Launch functionality make it possible for a mismatch of patient data.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm initiated recall via telephone on 8/23/07 to their customers who had the 2007 version in their production environment, explained the reason for recall, and informed them they should turn off the affected functionality. The firm posted details of the situation on their website in two different documents (referred to as a Priority Review Flash), one dated 8/29/07 and the other dated 8/31/07. The 8/31/07 document was also mailed to their customers via certified mail on 9/4/07. The corrected software (EP28822 ver.1) was made available to the firm's clients on 9/7/07 via their website. Beginning 9/18/07, workarounds were discussed via telephone with the clients who had downloaded the software correction which contained a new bug that affected the dictation file. A new software correction to fix the dication file problem was posted on the recalling firm's website on 9/28/07 for clients to download and validate. A Priority review Flash #PR07-0176-2 client notification dated 10/4/07 was also posted on their website and mailed via certified mail return receipt.
Quantity in commerce: Downloaded by 9 customers nationwide.
Distribution: Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.
Product codes and lots: Radiology 2007 Cumulative Production Package 25143

Product code LLZ

K022881Class IICedara I-SoftviewCedara Software Corp. / cleared 2002-10-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)