The Recall Desk
ModerateFDA (Devices)·Z-2042-2023·Announced 2023-07-05

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.

What this means for you

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
Hazard
  • login-failure
  • software-defect

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

Distributed in 9 states:

  • AZ
  • GA
  • IA
  • IN
  • MN
  • NE
  • NH
  • OH
  • TX