Z-2315-2021Class II

Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Name: Z-2315-2021 Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Creator: Philips North America Llc
Published: 2021-06-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-06-08 / Terminated / root cause: software

FDA source

Philips North America Llc began a recall of Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system on 2021-06-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2315-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-08
Posted: 2021-08-18
Terminated: 2023-08-10
Recalling firm: Philips North America LLC
Product: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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).
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Product codes and lots: Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 Software Version: 4.1.10 SynchRight Option

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2315-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2314-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18
Z-2315-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18
Z-2316-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18
Z-2317-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18
Z-2318-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-18

Product code JAK

K160743Class IIPhilips Ingenuity CTPhilips Medical Systems (Cleveland), Inc. / cleared 2016-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)