Z-2061-2015 Class II Terminated
FDA device recall Z-2061-2015 was initiated by AGFA Healthcare Corp. on Jun 26, 2015 and is designated Class II. Reason for recall: Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect. The recall status is terminated (terminated Jan 27, 2016). Affected quantity: 2.
Recall details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- Jun 26, 2015
- Termination Date
- Jan 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product description
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Reason for recall
Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.
Distribution pattern
Distributed in the state of MO.
Code information
N/A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2061-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026