Ingenuity CT recallZ-2315-2021 · Philips North America Llc · initiated Jun 8, 2021
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 North America Llc 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
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
FDA root cause category: Software design
What the company is doing
Philips issued Urgent Medical Device Correction letter dated 6/8/21 to consignees via certified mail. Letter states reason for recall, health risk and action to take: following steps: Go to Preferences> Regional Settings > Weight units, select the Weight units to Kg. Step 1: Verify that the patient weight unit is set to Kg, rather than Lbs. Step 2: Change the weight unit to Kg if weight unit is set to Lbs, referring to the screenshot below Step 3: Log out and then log back in to make the changes effective. Please share this notice with all those who need to be aware within your organization. Please complete and return the attached response form to Philips Healthcare promptly upon receipt and no later than 30 days from receipt, via email to [email protected] The software update is planned to be released in the 3rd quarter of 2021. Once the software update is released, a Philips representative will contact you to schedule a software update to permanently resolve the issue. For North America, contact the Customer Care Solutions Center (1-800-722-9377).
Recall details
- Recall number
- Z-2315-2021
- Status
- Terminated
- Initiated by the company
- Jun 8, 2021
- Recalling firm
- Philips North America Llc
- Quantity
- 2 units
- Product code
- JAK
- FDA submissions
- K160743
- Distribution
- US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Product description
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Code information (models, lots, serial numbers)
Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 Software Version: 4.1.10 SynchRight Option
Devices named in this recall
2 devices 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 recalls1 death9 reports
- 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 88336).
- Z-2314-2021 · Terminated728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
- Z-2317-2021 · Terminated728332 IQon Spectral CT-Computed Tomography X-ray system
- Z-2318-2021 · Terminated728333 Spectral CT 7500 -Computed Tomography X-ray system
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.
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