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.
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, 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…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 32
Distribution
Related recalls
Same manufacturer · Philips Medical Systems (Cleveland) Inc
See all →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled Due to Detector Falling Hazard
FDA (Devices) · 2019-11-13
- SeverePhilips Recalls Forte Gamma Camera Systems Due to Detector Fall Risk
FDA (Devices) · 2019-11-13
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12
Similar recalls
- ModeratePhilips Ingenuity TF PET/CT Software Recall for Reconstruction Failures
FDA (Devices) · 2018-02-21
- HighIngenuity CT scanners recalled because the patient couch may descend unexpectedly
FDA (Devices) · 2025-10-01
- ModeratePhilips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console
FDA (Devices) · 2018-04-25
- HighPhilips Ingenuity Core CT Systems Recalled for Couch Movement Hazard
FDA (Devices) · 2018-04-25
- HighPhilips Ingenuity CT Recall for Emergency Stop Defect
FDA (Devices) · 2018-04-25
- ModeratePhilips Ingenuity TF PET/CT Recalled for Cardiac Image Labeling Error
FDA (Devices) · 2019-08-14