Philips ProxiDiagnost N90 radiography system: firmware issue causes incorrect radiation dose
Philips is recalling 140 ProxiDiagnost N90 radiography systems due to a firmware issue in the Wallstand VS2 component. After system restart or first exposure with Wallstand VS2, the system may deliver incorrect radiation doses and misposition anatomic 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 recall of a radiography system with potential for incorrect radiation dosing and anatomic misidentification. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Philips Medical Systems DMC GmbH is recalling ProxiDiagnost N90 radiography and fluoroscopy systems for a firmware issue affecting the Wallstand VS2 component. The recall involves 140 systems distributed nationwide.
The firmware issue in the Wallstand VS2 board causes the system to rotate the radiation field selection by 90 degrees. This occurs when the system is restarted with Table Height 2 as the default setting and then switched to Wallstand VS2, or after the first exposure using Wallstand VS2 followed by a system restart. The incorrect field selection may cause an incorrect radiation dose. The anatomic position markers may also become mispositioned and could potentially correspond to the opposite side of the anatomy being examined.
The recalled product
- Product
- ProxiDiagnost N90. 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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