CLASS II Device recall · Reported 19 Feb 2014 · FDA Enforcement Report

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

Mckesson Information Solutions is recalling Horizon Medical Imaging, Picture Archive Communication System (PACS), distributed nationwide in the US. The recall was initiated on 23 Dec 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHMI 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.

Quantity recalled618 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0976-2014
FDA event ID: 67374
Recalling firm: Mckesson Information Solutions, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 23 Dec 2013
FDA classified: 12 Feb 2014
Reported: 19 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

23 Dec 2013	Recall initiated by company
12 Feb 2014	Classified by FDA	+51 days
19 Feb 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
29 Oct 2014Device	CLASS II	McKesson Cardiology Hemo recalled by Mckesson Information Solutions	Mckesson Information Solutions	Other	Nationwide
15 Oct 2014Device	CLASS II	McKesson Cardiology" Hemo intended recalled	Mckesson Information Solutions	Device Malfunction	Nationwide
1 Jan 2014Device	CLASS II	McKesson Radiology 12.0, Picture Archiving Communication recalled	Mckesson Information Solutions	Other	4 states
9 Oct 2013Device	CLASS II	McKesson Horizon Medical Imaging recalled	Mckesson Information Solutions	Device Malfunction	PR

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