The Recall Desk
HighFDA (Devices)·Z-2520-2023·Announced 2023-10-11

Philips Incisive CT Software Version 5.0 Recall for Scan Parameter Issues

Philips is recalling Incisive CT software version 5.0 in 140 systems nationwide due to three compliance issues that may affect scan timing and imaging parameters.

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 medical device recall involving identified software defects that could affect diagnostic imaging accuracy. The issues represent compliance concerns and potential for patient harm through incorrect scan parameters or timing, though no illnesses or injuries have been reported.

Plain-English summary

Philips Healthcare is recalling Incisive CT software version 5.0 affecting 140 systems distributed nationwide due to three identified software compliance issues.

The identified issues are: (1) Coronary computed tomography angiography (CTA) scans may not initiate at the optimal time, (2) Using an aborted surview scan for scan planning will result in deviation from the intended scan area, and (3) Clinical scans performed with a bariatric (Noah) couch may deviate from the intended scan area if the surview scan length exceeds 1832 millimeters.

No illnesses or injuries related to these issues have been reported to date.

The recalled product

Product
Incisive CT, software version 5.0
Manufacturer
Philips Healthcare
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
  • scan-timing-defect
  • scan-parameter-deviation
  • software-malfunction

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)

  • software version 5.0

Distribution

Distributed nationwide across the United States.

Related recalls

Same category