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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems DMC GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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