Philips Healthcare DuraDiagnost stationary X-ray system
FDA device recall Z-1696-2016 · posted 2016-06-03 · Terminated
Recall details
- Recalling firm
- Philips Healthcare
- Reason for recall
- The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.
- Action taken
- Philips Healthcare plans to correct the defect at no cost to customers by implementing a field correction involving the installation of new software. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call 1-800- 722-9377.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 5
- Distribution
- USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN,
- Date initiated
- 2015-11-10
- Date posted
- 2016-06-03
- Date terminated
- 2017-05-03
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURADIAGNOST (K141381) | Philips Healthcare (Suzhou) Co., Ltd. | 2014-06-12 |