DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic ima
FDA device recall Z-1799-2010 · posted 2010-06-11 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- The RF tags on the white protection sheets of the media stacks were incorrect.
- Action taken
- AGFA Healthcare issued an "Urgent Safety Notice" dated April 22, 2010 requesting a check of warehouse inventory and a request for a sub-recall, if necessary. All affected product should be returned to the firm for replacement. For further information, contact AGFA Healthcare at 1-877-777-2432.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 180 boxes
- Distribution
- Worldwide Distribution -- United States (AL, CT, FL, KS, MA, MI, NJ, NM, NY, PA and WV), British Columbia and Guatemala.
- Date initiated
- 2010-04-22
- Date posted
- 2010-06-11
- Date terminated
- 2011-02-01
- Location
- Greenville, SC
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