Philips Ingenuity Digital PET/CT System Recall for Pallet Assembly Defect
Philips is recalling 32 Ingenuity Digital PET/CT Systems because a block connecting the patient pallet to the couch may be assembled incorrectly, potentially causing a misaligned screw.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a mechanical assembly defect (misaligned screw) without reported harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 32 units of the Ingenuity Digital PET/CT System, Model 882446. The recall is due to a potential assembly error in the block used to connect the patient pallet to the couch. Specifically, a screw may be misaligned in the patient pallet.
The affected systems are distributed worldwide, including in the United States (CA, GA, LA, MD, MI, NY, OH, TN, TX, VT, Washington DC & WI) and internationally in Canada, Mexico, Belgium, France, Israel, Luxembourg, Netherlands, Singapore, Spain & Switzerland. The specific serial numbers affected range from 900004 to 900035.
Healthcare facilities should contact Philips Medical Systems for instructions on how to correct the assembly issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01)00884838059559(21)900004 (01)00884838059559(21)900005 (01)00884838059559(21)900006 (01)00884838059559(21)900007 (01)00884838059559(21)900008 (01)00884838059559(21)900009 (01)00884838059559(21)9000
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 32
Distribution
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