Ingenuity CT recallZ-2274-2018 · Philips Medical Systems (Cleveland) Inc · initiated Mar 28, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips Medical Systems (Cleveland) Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
FDA root cause category: Other
What the company is doing
Urgent Field Safety Notice letters were sent to customers on 3/28/18. The letters did not request any actions to be conducted by the customers. For Brilliance Big Bore/ Ingenuity CT / Ingenuity Core / Ingenuity Corel 28 Customers: A Philips Field Service Engineer will contact you to schedule the FCO updates at your site. Field Change Order (FCO 72800691 and 72800692) will be released to correct the issue. For Ingenuity TF PET/CT Customers: Field Change Order (FCO 88200520 and 88200511) will be released to correct this issue. A Philips Field Service Engineer will contact you to schedule the FCO updates at your site.
Recall details
- Recall number
- Z-2274-2018
- Status
- Terminated
- Initiated by the company
- Mar 28, 2018
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 28 total
- Product code
- JAK
- FDA submissions
- K160743
- Distribution
- The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
Product description
Philips Ingenuity Core 728321
Code information (models, lots, serial numbers)
UDI: (01)00884838059498(21)333169, Serial Number: 333169; UDI: (01)00884838059498(21)310377, Serial Number: 310377; UDI: (01)00884838059498(21)310375, Serial Number: 310375; UDI: (01)00884838059498(21)333171, Serial Number: 333171; UDI: (01)00884838059498(21)333172, Serial Number: 333172
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ingenuity CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed5 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 80176).
- Z-2273-2018 · TerminatedBrilliance Big Bore Radiology 728244
- Z-2275-2018 · TerminatedIngenuity Core128 728323
- Z-2276-2018 · TerminatedIngenuity TF PET/CT 882442
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page