Recall Z-2316-2021 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
| Date | Jun 8, 2021 |
| Status | Terminated |
| Reason | 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 | 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. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc., Aug 8, 2016 |