728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Recall
- Recall Number
- Z-2314-2021
- Event Number
- 88336
- Firm
- Philips North America Llc
- FEI Number
- 3016618143
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 8, 2021
- Terminated
- August 10, 2023
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289
Description
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
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.
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).
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
3 units