Radiography System Firmware Error May Cause Incorrect Radiation Dose
Philips DigitalDiagnost 4 radiography systems may deliver incorrect radiation doses due to a Wallstand VS2 firmware issue causing incorrect image orientation and misaligned anatomical markers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II with no reported illnesses or hospitalizations. The potential for incorrect radiation doses and misaligned anatomical markers represents a risk-of-harm product where injury has not yet been reported, matching the rubric criterion for Score 3 (High).
Plain-English summary
Philips Medical Systems DMC GmbH is recalling 140 DigitalDiagnost 4 High Performance radiography and fluoroscopy systems distributed nationwide in the United States. The systems are affected by a firmware issue in the Wallstand VS2 component.
When the system restarts with Table Height 2 (TH2) as the default setting and is then switched to Wallstand VS2, the firmware incorrectly rotates the amplimat field selection by 90 degrees on the first examination. This incorrect field selection may result in an incorrect radiation dose being delivered to patients. Anatomic position markers may also become mispositioned and could potentially be associated with the opposite side of the anatomy.
The root cause was expanded to include instances where the incorrect amplimat field selection occurs following the first exposure using Wallstand VS2 and a subsequent system restart.
Affected facilities should verify their device serial numbers against the recall list and contact Philips Medical Systems for guidance on service or replacement.
The recalled product
- Product
- DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
- Manufacturer
- Philips Medical Systems DMC GmbH
- Hazard
- radiation-dose-error
- image-orientation-error
- anatomical-marker-misalignment
Distribution
Distributed nationwide across the United States.
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