| Class 2 Device Recall Horizon Medical Imaging | |
Date Initiated by Firm | February 18, 2016 |
Create Date | March 17, 2016 |
Recall Status1 |
Terminated 3 on August 28, 2018 |
Recall Number | Z-1182-2016 |
Recall Event ID |
73452 |
510(K)Number | K043146 |
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. |
Code Information |
McKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1 |
Recalling Firm/ Manufacturer |
Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia
|
For Additional Information Contact | Paul Sumner 404-338-3556 |
Manufacturer Reason for Recall | McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient. |
FDA Determined Cause 2 | Software design |
Action | McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Immediate actions to take to reduce the risk to patient
All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009:
1) To acknowledge that they have read and understood this Field Safety Notice
And
2) Arrange installation of software update/upgrade.
This notice should be distributed to all personnel within your organization who need to be aware of this issue and the required actions, and alert other affiliated parties that are affected by this Field Safety Notice.
For further questions, please call (404) 338-3556 |
Quantity in Commerce | 631 devices |
Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia |
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
|
|
|
|