McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
FDA device recall Z-0556-2014 · posted 2013-12-20 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- When merging two patient records into one patient record using McKesson Radiology 12.0, the resulting patient record is missing the Contrast Allergy information for the second patient record.
- Action taken
- Consignees were notified via letter (Field Safety Notice) on 10/15/2013.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6 units
- Distribution
- MO, NY, TN, WV and France.
- Date initiated
- 2013-10-15
- Date posted
- 2013-12-20
- Date terminated
- 2014-06-03
- 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 |