—#188424

Product

728333 Spectral CT 7500 -Computed Tomography X-ray system

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K203020
Affected lot / code info: Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option

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.

Root cause (FDA determination)

Software design

Action the firm took

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 CTNM.QARA@PHILIPS.COM 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).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

Timeline

Recall initiated: 2021-06-08
Terminated: 2023-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.