CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Agfa Digital Radiography X- Ray system DR 800 with Musica Dynamic recalled
Agfa N.V is recalling Agfa Digital Radiography X- Ray system DR 800 with Musica Dynamic, distributed nationwide in the US. The recall was initiated on 27 Jun 2019 and the FDA has classified it as Class II.
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-2056-2019
- FDA event ID
- 83400
- Recalling firm
- Agfa N.V, Mortsel, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2019
- FDA classified
- 30 Jul 2019
- Reported
- 7 Aug 2019
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 27 Jun 2019 | Recall initiated by company | |
| 30 Jul 2019 | Classified by FDA | +33 days |
| 7 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Agfa Digital Radiography X- Ray system DR 800 with Musica Dynamic recalled?
Yes. Agfa N.V recalled Agfa Digital Radiography X- Ray system DR 800 with Musica Dynamic on 27 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2056-2019.
Why was it recalled?
The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
Which lots are affected?
Model/Serial Number/s: 00925, 00945, and 00949, 1136
Where was it sold?
US Nationwide Distribution
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 N.V
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DR 800. Digital Radiography X-ray System recalled by Agfa N.V | Agfa N.V | Other | Nationwide |
| Device | CLASS II | Agfa DX-D 100 system-Digital Radiography mobile X-ray System recalled | Agfa N.V | Device Malfunction | Nationwide |
| Device | CLASS II | Agfa Digital Radiography X- Ray system DR recalled by Agfa N.V | Agfa N.V | Other | Nationwide |
| Device | CLASS II | AGFA Digital Radiography X- Ray system DR recalled by Agfa N.V | Agfa N.V | Other | Nationwide |
| Device | CLASS III | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film recalled | Agfa N.V | Other | Nationwide |
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