The Recall Desk
HighFDA (Devices)·Z-1584-2023·Announced 2023-05-24

Spectral CT X-Ray System Foot Switch May Entrap Operator's Foot

The Spectral CT 7500 foot switch unload pedal may entrap an operator's foot, risking injuries including fracture and dislocation. Philips is recalling 92 units with worldwide distribution.

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 a Class II medical device recall with an identified foot-entrapment hazard posing risk of serious injury (fracture, dislocation, loss of function). No illnesses or injuries have been reported, which limits severity to High per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Spectral CT 7500 Computed Tomography X-Ray System (Model 728333), manufactured by Philips North America LLC, is the subject of this recall due to a foot switch hazard.

Pressing the unload pedal on the foot switch may cause the operator's foot to become entrapped. If entrapment occurs, the operator faces risk of injury including pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

The recall affects 92 units distributed worldwide. In the United States, devices are located in Arizona, Indiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, and Texas. Internationally, devices have been distributed to Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, and the United Kingdom.

The recalled product

Product
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Manufacturer
Philips North America Llc
Hazard
  • foot-entrapment
  • fracture
  • joint-dislocation
  • ligament-sprain
  • muscle-sprain
  • laceration

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)

  • UDI-DI: 00884838101111

Distribution

Distributed nationwide across the United States.