Skip to content
Recall Observatory FDA recall evidence

Device product

Horizon Medical Imaging, Picture Archive Communication System (PACS).

Z-0976-2014

December 23, 2013

Class II

Product summary

Firm
Mckesson Information Solutions LLC
Event
Event 67374
Status
Terminated
Classification
Class II
Quantity
618 units
Official record key
device-enforcement:Z-0976-2014

Official wording

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.

Code information: 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.

Distribution pattern: U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.