DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
FDA device recall Z-0464-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee.
- Action taken
- Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- One unit
- Distribution
- Nationside Distribution: to NJ.
- Date initiated
- 2010-10-08
- Date posted
- 2010-11-26
- Date terminated
- 2010-12-30
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS (K092238) | Agfa Healthcare N.V. | 2009-08-11 |