Recall Z-1698-2017— AGFA Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Healthcare Corp., initiated 2016-01-20, terminated 2017-04-10. It names one FDA 510(k) clearance: K103597. Product: AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Reason: The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored..
- Recalling firm
- AGFA Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-20
- Terminated
- 2017-04-10
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
Reason for recall
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
Data sourced from openFDA. This site is unofficial and independent of the FDA.