Philips Gemini TF Big Bore PET/CT Systems Recalled for Mechanical Binding

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 47 units of the GEMINI TF Big Bore PET/CT, Computer Tomography System. The recall involves specific serial numbers listed in the agency record, including units 9004 through 9023 and 9201 through 9231.

The recall was issued because the TF Big Bore patient table experienced mechanical binding during horizontal table motion. This mechanical issue results in an automatic Emergency Stop (E-stop), which interrupts the current scan and results in an incomplete study.

The affected products were shipped to 21 U.S. states, including AR, CA, CO, FL, IL, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, PA, TX, VA, VT, and WI. The products were also shipped to 11 countries, including Belgium, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, Saudi Arabia, and Venezuela. Healthcare facilities should contact the recalling firm for instructions on how to address the mechanical binding issue.

The recalled product

Product

GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

Manufacturer

Philips Medical Systems (Cleveland) Inc

Category

Medical Device — Imaging Equipment

Hazard

• mechanical-binding
• scan-interruption

Affected units

47

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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