Z-2176-2014 Class III Terminated
FDA device recall Z-2176-2014 was initiated by AGFA Healthcare Corp. on May 13, 2014 and is designated Class III. Reason for recall: Unit was mislabeled with a factory label showing 32 KW output power. The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 1.
Recall details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- May 13, 2014
- Termination Date
- Aug 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product description
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Reason for recall
Unit was mislabeled with a factory label showing 32 KW output power.
Distribution pattern
US in the state of WV
Code information
Serial Number A5410000042
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2176-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026