DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
This recall has been terminated (originally issued August 10, 2014).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- July 2, 2014
- Posted
- August 10, 2014
- Terminated
- June 4, 2015
- Recall Number
- Z-2175-2014
- Quantity
- 17 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
Distribution
Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
Lot / Code Info
Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105
Root Cause
Device Design
Action Taken
AGFA HealthCare sent an URGENT FIELD SAFETY NOTICE letter dated July 2, 2014 to affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgment form, via FAX-Back or email. A Mandatory Service Bulletin DIS012.14E/No. 32, was released June 30, 2014, to implement the mandatory upgrade of full automatic DX-D600 systems to version 3.6 to prevent unexpected system movements. This Mandatory Service Bulletin was issued to Agfa DR Specialists to perform the service. A 2nd release will be implemented to upgrade semi-automatic systems. For questions contact your local AGFA HealthCare organization 1-877-777-2432.