Philips Gemini TF PET/CT Systems Recalled for E-Stop Malfunction
Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional failure that renders the device inoperable, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 33 units of the GEMINI TF PET/CT16, GEMINI TF PET/CT 64, and GEMINI TF Big Bore diagnostic imaging systems. These systems combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) for fixed or mobile installations.
The recall is due to a random software issue where a "Close Estop" message may appear to the operator during the startup procedure. This message disappears before the operator can take action, resulting in an inability to close the E-Stop. Consequently, the system becomes inoperable for clinical use.
The affected units were distributed in California, Colorado, Illinois, Oklahoma, Oregon, and Wisconsin. Healthcare facilities should contact Philips Medical Systems for further instructions on how to resolve the issue.
The recalled product
- Product
- GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 33
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)
- GEMINI TF PET/CT16: 882470 7019
- 7039
- 7099
- 7588
- 7593
- 7598
- 7599
- 7600
- 7604
- 7605
- 7596M GEMINI TF PET/CT 64: 882471 7027
- 7044
- 7146
- 7153
- 7178
- 7182
- 7188
- 7578
- 7579
- 7585
Distribution
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