Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8. Horizon Medical Imaging is a medical image a
FDA device recall Z-3035-2011 · posted 2011-08-18 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- Images for one patient may appear in the study of another patient.
- Action taken
- Mckesson Medical Imaging Group sent a URGENT FIELD SAFETY NOTICE letter dated June 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. On February 2, 2011, the McKesson Medical Imaging company initiated a process for applying an image display software update to the HMI systems at the hospital site that initiated the complaint. They were advised to contact McKesson Customer Support at 1-800-663-2533, to indicate whether they would like to receive the software update. They were advised to distribute the notification to all those within their organization who need to be aware and to alert other parties affiliated with their organization that are affected by this advisory notice.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 438 devices
- Distribution
- Worldwide Distribution--USA (nationwide) Australia, Canada, Guam and the United Kingdom.
- Date initiated
- 2011-02-02
- Date posted
- 2011-08-18
- Date terminated
- 2012-10-04
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON MEDICAL IMAGING (K043146) | Mckesson Medical Imaging Company | 2005-01-04 |