Z-0919-2014 Class II Terminated
FDA device recall Z-0919-2014 was initiated by AGFA Corp. on January 8, 2014 and is designated Class II. Reason for recall: Patient name displayed (printed) on the Patient Report was the wrong patient name. The recall status is terminated (terminated February 28, 2014). Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2014
- Initiation Date
- January 8, 2014
- Termination Date
- February 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
IMPAX RIS QDOC 5.8
Reason for Recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
Distribution Pattern
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Code Information
Software IMPAX RIS 58 and higher