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.
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: 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
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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