Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Diagnostic imaging systems (GEMINI LXL Model #882412 Recalled by Philips Medical Systems (Cleveland) Inc Due to The PET Reconstruction Server (PRS) database may randomly...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
Quantity: 386 units
Why Was This Recalled?
The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study.
Where Was This Sold?
This product was distributed to 35 states: AL, AZ, AR, CA, CO, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OR, PA, TN, TX, VT, VA, WA, WI, DC
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report