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

FDA device recall Z-1243-2007 · posted 2007-09-25 · Terminated

Recall details

Recalling firm

Cerner Corp

Reason for recall

Defects in the Auto Launch functionality make it possible for a mismatch of patient data.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

Downloaded by 9 customers nationwide.

Distribution

Distribution was made to health care facilities located in LA, MO, NJ, MS, MI, NE, ND, and AR.

Date initiated

2007-08-23

Date posted

2007-09-25

Date terminated

2007-11-29

Location

Kansas City, MO

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