FDA Medical Device Recalls (openFDA)
Mckesson Information Solutions LLC: Horizon Medical Imaging, Picture Archive Communication System (PACS).
- Recall number
- Z-0976-2014
- Recalling firm
- Mckesson Information Solutions LLC
- Product
- Horizon Medical Imaging, Picture Archive Communication System (PACS).
- Status
- Terminated
- Initiated
- 2013-12-23
- Posted
- 2014-02-12
- Terminated
- 2017-04-25
- Reason
- Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
- Root cause
- Software design
- Action
- McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
- Quantity
- 618 units
- Distribution
- U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
- Lot, serial or model codes
- HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.
- 510(k) numbers
- ["K043146"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002684279
- Firm city
- Alpharetta
- Firm state
- GA
- 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