The Recall Desk
HighFDA (Devices)·Z-2357-2021·Announced 2021-09-08

Medical Imaging Software Bug May Cause Incorrect X-ray Exposure

Philips CombiDiagnost R90 imaging software has a bug where exposure settings may change unexpectedly, resulting in over or under-exposed X-ray images. About 66 systems in the US are affected.

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 recall of a diagnostic medical device with a software defect that poses a risk of harm through incorrect image quality and exposure control, but no reported illnesses or injuries to date.

Plain-English summary

Philips Medical Systems is recalling the CombiDiagnost R90 radiographic imaging system (software versions R1.0 and R1.1, model 706100) due to a software bug affecting X-ray exposure control.

The bug occurs when the collimator shutter position is changed immediately after the Lock-In command. When this happens, the kV (kilovoltage) and mA (milliamperage) values—which control X-ray exposure intensity—do not remain locked as intended and may change unexpectedly. This results in X-ray images that are either over-exposed or under-exposed, potentially compromising diagnostic image quality.

Approximately 66 systems are affected in the United States. The recall applies to all units running software versions R1.0 and R1.1. Customers and healthcare facilities using this equipment should contact Philips for a software update or corrective instructions.

The recalled product

Product
CombiDiagnost R90 Software Version R1.0 and R1.1
Manufacturer
Philips Medical Systems Gmbh, DMC
Category
Medical Device — Radiographic Imaging
Hazard
  • software-defect
  • x-ray-exposure-error
  • image-quality-degradation

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 706100

Distribution

Distributed nationwide across the United States.

Related recalls

Same category