Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose
Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.
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: Class II recall involving potential incorrect radiation dose and anatomic positioning errors in a diagnostic imaging system. The risk of harm to diagnostic accuracy and patient care, combined with the technical defect's serious implications, justifies High severity per the rubric for risk-of-harm products.
Plain-English summary
Philips North America LLC is recalling 11 DigitalDiagnost C50 1.1 radiography systems distributed nationwide, including Puerto Rico. The affected serial numbers are: 210182, 210187, 220002, 210049, 210051, 210097, 210052, 210053, 210055, and 220020.
A firmware defect in the Wallstand VS2 board causes the system to incorrectly rotate the amplimat field selection by 90 degrees. Following a system restart where Table Height 2 (TH2) is the default setting and the system is switched to Wallstand VS2, operators will see an incorrect image orientation on the first examination. The incorrect amplimat field selection may result in an incorrect radiation dose being delivered. Additionally, anatomic position markers may become mispositioned and could be associated with the opposite side of the anatomy, potentially affecting diagnostic accuracy.
As of January 3, 2023, the scope of the defect was expanded to include incorrect amplimat field selection that also occurs following the first exposure using Wallstand VS2 and a subsequent system restart, in addition to the original issue identified with the system restart scenario.
The recalled product
- Product
- DigitalDiagnost C50 1.1
- Manufacturer
- Philips North America Llc
Distribution
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