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U.S. Department of Health and Human Services

Class 2 Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report

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  Class 2 Device Recall Cerner Millennium RadNet Auto Launch Study and Auto Launch Report see related information
Date Initiated by Firm August 23, 2007
Date Posted September 25, 2007
Recall Status1 Terminated 3 on November 29, 2007
Recall Number Z-1243-2007
Recall Event ID 44739
510(K)Number K022881  
Product Classification radiology software - Product Code LLZ
Product Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
Code Information Radiology 2007 Cumulative Production Package 25143
Recalling Firm/
Cerner Corp
2800 Rockcreek Pkwy
Kansas City MO 64117-2521
For Additional Information Contact Shelley S. Looby, BS MT(ASCP)BB
Manufacturer Reason
for Recall
Defects in the Auto Launch functionality make it possible for a mismatch of patient data.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = CEDARA SOFTWARE CORP.