Z-2176-2014 Class III Terminated

Recalled by AGFA Healthcare Corp. — Greenville, SC

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