Philips Spectral CT Computed Tomography X-ray System Software

Plain-English summary

Philips North America LLC is recalling Spectral CT computed tomography X-ray systems due to software issues. Devices with the affected software may experience two unintended motion issues that could result in contact between the gantry or table and the operator or patient. The recall also affects additional software issues that may degrade CT performance.

The affected systems were distributed domestically across 19 U.S. states (Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, and West Virginia) and internationally across 38 countries and territories.

Approximately 370 units of the Spectral CT system are affected, identified by Part No. 728333 with multiple serial numbers and UDI codes. Facilities and operators who use these systems should contact Philips North America LLC for information regarding the software update or corrective action.

The recalled product

Product

Spectral CT. Computed tomography X-ray system.

Manufacturer

Philips North America Llc

Category

Medical Device — Imaging Equipment / Computed Tomography

Hazard

• contact-hazard
• gantry-motion
• table-motion
• 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.

Distribution

Related recalls