Philips North America Llc 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option
Philips North America Llc is recalling 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades due to When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026