FDA Medical Device Recalls (openFDA)
Cerner Corp: Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
- Recall number
- Z-1243-2007
- Recalling firm
- Cerner Corp
- Product
- Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
- Status
- Terminated
- Initiated
- 2007-08-23
- Posted
- 2007-09-25
- Terminated
- 2007-11-29
- Reason
- Defects in the Auto Launch functionality make it possible for a mismatch of patient data.
- 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
- Downloaded by 9 customers nationwide.
- Distribution
- Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.
- Lot, serial or model codes
- Radiology 2007 Cumulative Production Package 25143
- 510(k) numbers
- ["K022881"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1931259
- Firm city
- Kansas City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28