Philips Gemini TF Big Bore PET/CT Systems Recalled for Mechanical Binding
Philips is recalling 47 Gemini TF Big Bore PET/CT systems because the patient table can mechanically bind, causing an automatic emergency stop and incomplete scans.
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: The recall involves a high-risk medical device where a mechanical defect can interrupt a scan, but the source text does not report any injuries, illnesses, or fatalities.
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
- 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.
Lot numbers (20)
- Model #882476
- Serial #'s: 9004
- 9005
- 9006
- 9008
- 9009
- 9010
- 9011
- 9012
- 9013
- 9014
- 9015
- 9016
- 9017
- 9018
- 9019
- 9020
- 9021
- 9022
- 9023
Distribution
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