Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected t
FDA device recall Z-1062-2012 · posted 2012-02-19 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- The firm received a complaint that when using the DX-D Mobile DR X-Ray unit they noticed the detector cable was hot.
- Action taken
- AGFA Corp. sent an "URGENT FIELD SAFETY NOTICE" letter dated January 16, 2012 to affected consignees. The letter described the affected product, concerns, issues and actions to be taken. Customers have been requested to place the Varian warning label included in a highly visible and suitable position on the cable of the portable detector. Customers were instructed to complete and return the feedback form by fax to 864-421-1664, as soon as possible. For questions about this matter contact your local AGFA HealthCare Technical Support at 877-777-2432.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 42 units
- Distribution
- Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.
- Date initiated
- 2012-01-16
- Date posted
- 2012-02-19
- Date terminated
- 2012-05-10
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DX-D IMAGING PACKAGE (K092669) | Agfa Healthcare N.V. | 2009-11-06 |