CLASS III Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Agfa Digital Radiography X-Ray System DX-D recalled by AGFA Healthcare
AGFA Healthcare is recalling Agfa Digital Radiography X-Ray System DX-D 100, distributed in West Virginia. The recall was initiated on 13 May 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2176-2014
- FDA event ID
- 68798
- Recalling firm
- AGFA Healthcare, Greenville, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 May 2014
- FDA classified
- 9 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 13 May 2014 | Recall initiated by company | |
| 9 Aug 2014 | Classified by FDA | +88 days |
| 20 Aug 2014 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unit was mislabeled with a factory label showing 32 KW output power.
Product as listed by the FDA
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.
Where it was distributed
US in the state of WV
Questions about this recall
Is Agfa Digital Radiography X-Ray System DX-D 100 recalled?
Yes. AGFA Healthcare recalled Agfa Digital Radiography X-Ray System DX-D 100 on 13 May 2014. The recall is Class III and its status is Terminated. Recall number Z-2176-2014.
Why was it recalled?
Unit was mislabeled with a factory label showing 32 KW output power.
Which lots are affected?
Serial Number A5410000042
Where was it sold?
US in the state of WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AGFA Healthcare
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|---|---|---|---|---|---|
| Device | CLASS II | Brand name: Agfa Digital Radiography X- Ray system DR recalled | AGFA Healthcare | Other | Nationwide |
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