Radiography system firmware bug may cause incorrect radiation doses
Certain Philips DigitalDiagnost C90 X-ray systems contain a firmware defect that can cause incorrect radiation doses and misaligned anatomic position markers when using the Wallstand VS2 board.
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: This recall addresses a firmware defect that may cause incorrect radiation doses and anatomic positioning errors in radiography systems. Although classified as FDA Class II, no illnesses or injuries have been reported. The documented hazard has not yet resulted in actual patient harm.
Plain-English summary
Philips Medical Systems DMC GmbH is recalling 140 DigitalDiagnost C90 High Performance radiography and fluoroscopy systems distributed nationwide. These systems have a firmware defect in the Wallstand VS2 board.
The defect causes the system to incorrectly rotate the amplimat field selection by 90 degrees following certain system restart conditions or after the first exposure when using the Wallstand VS2 board. An incorrect amplimat field selection may cause an incorrect dose of radiation to be delivered. Additionally, the anatomic position markers may become mispositioned and could appear to represent the opposite side of anatomy.
The affected systems include Model 712034 with specific serial numbers listed in the FDA recall notice. Healthcare facilities with potentially affected equipment should contact Philips Medical Systems for a firmware update and corrective instructions.
The recalled product
- Product
- DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
- Manufacturer
- Philips Medical Systems DMC GmbH
- Hazard
- incorrect-radiation-dose
- anatomic-positioning
- firmware-defect
Distribution
Distributed nationwide across the United States.
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