FDA Recall Terminated

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 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: chest, abdomen, and other body parts.

Recall: Z-1487-2013 · Initiated May 15, 2013

Recall

Recall Number
Z-1487-2013
Event Number
65223
Firm
AGFA Corp.
FEI Number
3001236302
Product Code
IZL
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
May 15, 2013
Posted
June 6, 2013
Terminated
December 31, 2014
Address
10 S Academy St, Greenville, SC, 29601-2632

Description

AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 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: chest, abdomen, and other body parts.

Reason

Customers could potentially experience intermittent, unintended and illogical movement when using the product.

Action

Agfa sent an "URGENT SAFETY NOTICE" letter dated May 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed if you experience unintended movement, the unit has to be taken out of operation. Please notify you Agfa service contact at once. Please distribute this information within your facility to all those who need to be aware of this. Please complete the feedback form as soon as possible and return to us. For further questions please call 1-877-777-2432.

Distribution

Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada

Quantity

104