Radiography system firmware defect causes incorrect radiation dose
Philips DigitalDiagnost C90 radiography systems have a firmware defect that may cause incorrect radiation doses and anatomic marker misalignment. The issue affects 140 systems nationwide with specific serial numbers.
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 is an FDA Class II medical device recall involving a risk-of-harm condition (incorrect radiation dosing and anatomic marker misalignment). The source text does not report any illnesses or injuries, so the hazard remains theoretical. This meets the criteria for a High severity classification.
Plain-English summary
Philips Medical Systems is recalling DigitalDiagnost C90 Flex/Value/Chest/ER radiography and fluoroscopy systems due to a firmware defect in the Wallstand VS2 board. A total of 140 units are affected and have been distributed nationwide. The affected serial numbers are 21862105, 21862107, 21862123, 21862126, and 22860027.
The firmware issue occurs when the system is restarted with Table Height 2 (TH2) as the default setting and then switched to Wallstand VS2, or after the first exposure using Wallstand VS2 followed by a system restart. In these scenarios, the firmware causes the amplimat field selection to rotate 90 degrees, which is incorrect. This incorrect field selection may result in an incorrect dose of radiation being delivered to the patient.
Additionally, anatomic position markers may become mispositioned and could be associated with the opposite side of the anatomy.
The recalled product
- Product
- DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
- Manufacturer
- Philips Medical Systems DMC GmbH
- Hazard
- incorrect-radiation-dose
- anatomic-misposition
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 712035 Serial Numbers 21862105 21862107 21862123 21862126 22860027
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01