Z-1735-2010

Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company...

Name: Z-1735-2010 Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company...
Creator: Mckesson Medical Immaging
Published: 2010-05-07
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2010-05-07 / Terminated / root cause: software

FDA source

Mckesson Medical Immaging began a recall of Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. Intended to receive... on 2010-05-07. The reason FDA records is "Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient". 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-1735-2010
Status: Terminated
Initiated: 2010-05-07
Posted: 2010-05-28
Terminated: 2012-08-15
Recalling firm: Change Healthcare Canada Company
Product: Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.
Root cause tag: software
FDA root cause: Software design
Action: McKesson Medical Imaging Company issued an "Advisory Notice" dated May 7, 2010. Consignees were notified of the affected product and advised to contact McKesson Customer Support department to review their sites current configuration and install the appropriate product software update(s). For further information, contact McKesson Medical Imaging Customer Support at 1-800-663-2533. On June 19, 2010 the recall was amended to include the following actions to follow: Instead of highlighting the anchor study in the Patient Portfolio Sidebar before saving t he voice clip in the Patient Portfolio Sidebar, McKesson recommends that you save the voice clip to the desired study first, before browsing through other documents. A software update that prevents the problem from occurring is currently under development for all affected releases and will be available in approximately three months. Consignees will be notified when the software update is ready to be installed on their system.
Quantity in commerce: 100 units
Distribution: Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada
Product codes and lots: Horizon Medical Imaging (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613. On June 29, 2010 the recall was amended to include: All installations of Horizon Medical imaging (HMI) 11.0.6, 11.0.8 and 11.5.1

Product code LLZ

K043146Class IIHorizon Medical ImagingMckesson Medical Imaging Company / cleared 2005-01-04

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)