DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the phys
FDA device recall Z-2175-2014 · posted 2014-08-10 · Terminated
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- Reason for recall
- Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
- Action taken
- AGFA HealthCare sent an URGENT FIELD SAFETY NOTICE letter dated July 2, 2014 to affected customers. The letter described the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgment form, via FAX-Back or email. A Mandatory Service Bulletin DIS012.14E/No. 32, was released June 30, 2014, to implement the mandatory upgrade of full automatic DX-D600 systems to version 3.6 to prevent unexpected system movements. This Mandatory Service Bulletin was issued to Agfa DR Specialists to perform the service. A 2nd release will be implemented to upgrade semi-automatic systems. For questions contact your local AGFA HealthCare organization 1-877-777-2432.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
- Date initiated
- 2014-07-02
- Date posted
- 2014-08-10
- Date terminated
- 2015-06-04
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DX-D 600 (K112670) | Agfa Healthcare N.V. | 2011-10-27 |