The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1055-2024·Announced 2024-02-14

Philips Spectral CT 7500 software issue causes incorrect image labeling

Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

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 3/5 (High).

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 for a software defect that can cause image mislabeling in diagnostic equipment, presenting a risk of patient harm through potential misdiagnosis and incorrect treatment. With no reported illnesses or injuries, this meets the criterion for score 3 (High) as a risk-of-harm product without reported incidents.

Plain-English summary

Philips Medical Systems has recalled Spectral CT 7500 medical imaging equipment due to a software issue in Version 5.0. The defect can incorrectly label captured diagnostic images, which may lead to misdiagnosis and subsequent incorrect patient treatment.

The affected devices include Model 728333 and Model 728340 units. In the US, 33 devices in the states of Arkansas, Arizona, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Texas, and West Virginia are affected. Additionally, 177 units have been distributed to healthcare facilities in Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, and the United Kingdom.

Healthcare providers and facilities using affected devices should contact Philips Medical Systems for guidance. Facilities should review recent diagnostic images generated by affected equipment and assess whether any patient care decisions may have been affected by potentially mislabeled images.

The recalled product

Product
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Manufacturer
PHILIPS MEDICAL SYSTEMS
Category
Medical Device — CT Scanner
Hazard

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)

  • UDI-DI: 00884838101111
  • Model 728333
  • serial numbers: 10197
  • 10182
  • 10175
  • 10192
  • 10179
  • 10196
  • 10180
  • 10188
  • 10190
  • 10181
  • 10183
  • 10178
  • 10186
  • 10185
  • 10199
  • 10184
  • 10198
  • 10193

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 2 recalled by PHILIPS MEDICAL SYSTEMS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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