Philips DigitalDiagnost C90 X-Ray Systems Software Login Issue
Philips is recalling DigitalDiagnost C90 diagnostic imaging systems due to a software login issue that may prevent users from logging in to the device. The recall affects 58 units distributed across the U.S. and internationally.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported deaths, hospitalizations, or confirmed adverse events. The hazard is a functional software defect (inability to log in) that prevents device use but poses no direct patient safety risk. This meets the Moderate classification for functional defects without reported harm.
Plain-English summary
Philips North America LLC is recalling the DigitalDiagnost C90 diagnostic imaging systems (Models 712034 and 712035) due to a software login issue that may prevent authorized users from logging in to the device.
The recall affects 58 units distributed in the United States across Arizona, Georgia, Indiana, Iowa, Minnesota, Nebraska, New Hampshire, Ohio, and Texas. Units were also distributed internationally to Australia, Chile, China, Malta, Namibia, New Zealand, Oman, Panama, Qatar, Suriname, and the United Kingdom. Affected devices can be identified by their specific serial numbers and UDI-DI codes listed in the recall notice.
Users and healthcare facilities with affected units should contact Philips North America LLC for guidance on remediation options or device replacement.
The recalled product
- Product
- DigitalDiagnost C90, Model No. 712034 and 712035
- Manufacturer
- Philips North America Llc
- Affected units
- 58
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 (20)
- 1) UDI-DI (01)00884838090699
- Model 712034
- serial numbers: 10000074
- 10000083
- 10000163
- 10000188
- 10001057
- 10001071
- 10001072
- 10001079
- 10001089
- 10001106
- 10001133
- 10001136
- 10001137
- 10001142
- 10001146
- 10001169
- 10001180
- 10001181
Distribution
Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- ModeratePhilips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
- ModeratePhilips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
- ModeratePhilips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Similar recalls
- HighPhilips DigitalDiagnost C90 radiography system ceiling-mount failure risk
FDA (Devices) · 2023-11-15
- ModeratePhilips DigitalDiagnost 3.1.x X-Ray System Recalled for Performance Issues
FDA (Devices) · 2017-06-21
- HighPhilips DigitalDiagnost C90 Radiographic Systems Recalled for Ceiling Mount Failure
FDA (Devices) · 2023-11-15
- LowPhilips Recalls Two DigitalDiagnost C50 X-ray Systems for Missing Labels
FDA (Devices) · 2019-10-02
- ModeratePhilips DigitalDiagnost Software Recall for X-ray System Stitching Defects
FDA (Devices) · 2018-10-31
- ModeratePhilips Healthcare DigitalDiagnost X-ray Systems Recalled for Image Acquisition Failures
FDA (Devices) · 2016-06-15