Philips recalls Brilliance 64 CT systems with specific serial numbers due to potential image labeling errors during cardiac step and shoot acquisitions, which could lead to incorrect phase tolerance application in scans.
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Philips is recalling certain Brilliance 64 CT scanners that may label images incorrectly during cardiac scans. This could cause misdiagnosis if the phase tolerance setting isn't properly applied, though the risk is limited to specific scan procedures.
During certain cardiac step and shoot acquisitions, the system may label images as if phase tolerance was applied when it wasn't. This could lead to misdiagnosis if the images are interpreted incorrectly, but the issue only affects specific scan procedures and not all imaging.
Healthcare facilities using the recalled Brilliance 64 CT systems with specific serial numbers are most at risk. Patients undergoing cardiac scans with these systems may receive incorrect image labeling if the phase tolerance setting is not properly applied.
Check if your Brilliance 64 CT scanner has a serial number listed in the provided range (e.g., 335, 338, 1897, 4001, etc.). The system was sold between 2009 and 2023.
Verify your system's serial number against the list of affected numbers provided in the recall notice.
The system may label images incorrectly during cardiac step and shoot acquisitions when phase tolerance is not properly applied, potentially leading to misdiagnosis.
No, the recall does not require stopping use. Healthcare facilities should check their serial numbers and follow the provided steps to verify if their system is affected.
Check your system's serial number against the list of affected numbers provided in the recall notice, which includes specific ranges like 335, 338, 1897, 4001, etc.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2191-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2191-2019 from Philips Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
