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Terminated

Philips Healthcare DuraDiagnost stationary X-ray system

FDA Recall Z-1696-2016 · Posted 2016-06-03

Recalling FirmPhilips Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2015-11-10
Date Terminated2017-05-03
Product Quantity5

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.

Firm Action

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

Distribution Pattern

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, MD, MS, ME, MO, NE, NY, ND, OH and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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