Solid State X-Ray Imager (Flat Panel/Digital Imager)
FDA adverse event reports and recall history for solid state x-ray imager (flat panel/digital imager) (product code MQB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,276
- Deaths
- 11
- Injuries
- 103
- Malfunctions
- 1,042
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-05Open, ClassifiedDevice Design
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
- 2025-11-07Open, ClassifiedDevice Design
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
- 2023-06-30Open, ClassifiedSoftware change control
DigitalDiagnost C90, Model No. 712034 and 712035
There is a software login in issue that may prevent the user from logging in.
- 2019-01-08TerminatedComponent design/selection
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without triggering the safety lock. This can lead to overloading of the safety cable, which is not designed to permanently carry the load of the lifting column or continuously move under load. This could cause material fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops unexpectedly, patients and users may be seriously injured.
- 2018-08-17TerminatedDevice Design
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-17TerminatedDevice Design
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-17TerminatedDevice Design
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-17TerminatedDevice Design
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-17TerminatedDevice Design
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- 2018-08-17TerminatedDevice Design
BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
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