Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose
Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems 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: This is a Class II recall with no reported injuries or hospitalizations. The defect presents a risk of incorrect radiation dosing and anatomical positioning errors in a medical imaging system. Since the hazard is real but no patient harm has been reported, this meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems is recalling 140 DigitalDiagnost 4 Flex/Value radiography and fluoroscopy systems distributed nationwide in the United States. The systems contain a firmware issue in the Wallstand VS2 board.
Following a system restart where Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, or following the first exposure using Wallstand VS2 and a subsequent system restart, the Wallstand VS2 firmware may rotate the amplimat field selection by 90 degrees. This can result in incorrect image orientation on the first examination and incorrect radiation dosing. Additionally, anatomic position markers may become mispositioned and could be associated with the opposite side of the anatomy.
The affected serial numbers are: 10001088, 10001097, 10001104, 10001112, 19000317, 10001095, 10001102, and 10001105.
Healthcare facilities operating these systems should contact Philips Medical Systems DMC GmbH for firmware updates or technical guidance to resolve this issue.
The recalled product
- Product
- DigitalDiagnost 4 Flex / Value. 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Philips Medical Systems DMC GmbH
See all →- ModerateDigitalDiagnost C90 systems recalled over ceiling carriages resisting vertical movement
FDA (Devices) · 2025-11-19
- ModerateRadiography systems recalled over ceiling carriages that are hard to move
FDA (Devices) · 2025-11-19
- ModeratePrecision CRF systems recalled over ceiling carriages that are hard to move
FDA (Devices) · 2025-11-19
- ModerateProxiDiagnost systems recalled over ceiling carriages that resist vertical movement
FDA (Devices) · 2025-11-19
- ModerateDigitalDiagnost 4 systems recalled over ceiling carriages hard to move
FDA (Devices) · 2025-11-19
Same hazard · radiation dose error
See all →- HighSiemens Interventional Fluoroscopic X-Ray System Software Communication Failure
FDA (Devices) · 2025-07-09
- HighRayStation radiation therapy software: incorrect density uncertainty calculations in dose planning
FDA (Devices) · 2025-02-26
- HighRadiation Therapy Planning System May Report Dose Values Too High
FDA (Devices) · 2024-05-08
- HighPhilips Radiography System Firmware Defect Risks Incorrect Radiation Dose
FDA (Devices) · 2022-09-07
- HighRadiography System Firmware Error May Cause Incorrect Radiation Dose
FDA (Devices) · 2022-07-20
Similar recalls
- HighPhilips Radiography System Firmware Defect Risks Incorrect Radiation Dose
FDA (Devices) · 2022-09-07
- ModeratePhilips Digital Diagnost Radiographic System Recalled for Image Rotation Errors
FDA (Devices) · 2013-03-13
- HighPhilips DigitalDiagnost 4 radiographic systems risk of ceiling mounting failure
FDA (Devices) · 2023-11-15
- ModeratePhilips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors
FDA (Devices) · 2013-03-06
- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12
- HighPhilips Digital Diagnost Radiographic System Recall Due to Footboard Defect
FDA (Devices) · 2014-04-30