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 August 13, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2014
- Initiation Date
- May 13, 2014
- Termination Date
- August 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