AGFA DX-D 100 is a mobile digital radiography x-ray system
FDA device recall Z-1745-2015 · posted 2015-06-10 · Terminated
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- Reason for recall
- When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
- Action taken
- AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 29, 2015, to all affected customers. The letter was either emailed or sent via FedEx to the US customers. When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Please distribute this information within your facility to all those who need to be aware of the notice. Please complete the feedback form as soon as possible and return it to us. We thank you for your careful attention to this issue and your continued support. If you have any questions about this matter, please contact your local Agfa HealthCare organization: 1-877-777-2432 and please reference PR1411200006 and PR1501190003.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 233 units
- Distribution
- US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.
- Date initiated
- 2015-05-29
- Date posted
- 2015-06-10
- Date terminated
- 2017-01-18
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DX-D 100 (K103597) | Agfa Healthcare N.V. | 2011-01-03 |