728333 Spectral CT 7500 -Computed Tomography X-ray system
FDA Recall Z-2318-2021 · Posted None
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Recalling FirmPhilips North America Llc
Recall StatusTerminated
Product CodeJAK
Date Initiated2021-06-08
Date Terminated2023-08-10
Product Quantity1 unit
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.
Firm 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).
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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