Dx-D 100
by Agfa Healthcare N.V. United States 510(k)
510(k) K103597 Product code IZL
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103597 | Date3 Jan 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-1462-2024
Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury
-
- Terminated Z-1698-2017
The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
-
- Terminated Z-1745-2015
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
-
- Terminated Z-2081-2014
When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
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- Terminated Z-2176-2014
Unit was mislabeled with a factory label showing 32 KW output power.
-
- Terminated Z-1487-2013
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Specification
- 510(k) Number
- FDA Product Code
- IZL
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Agfa Healthcare N.V.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K103597