Philips recalls specific iCT SP computed tomography x-ray systems (model #728311) due to potential image labeling errors during cardiac scans. Affected units have unique serial numbers listed in the recall notice.
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 iCT SP computed tomography x-ray systems that may label images incorrectly during cardiac scans. This could lead to misdiagnosis if the images are used for treatment decisions.
When performing specific cardiac scans, the system may incorrectly label images as if phase tolerance was applied when it wasn't. This could lead to misdiagnosis if the images are used for treatment decisions.
Healthcare facilities using the recalled iCT SP systems are affected. Medical professionals who operate these systems are most at risk of potential misdiagnosis.
Check for the model number 728311 and system serial numbers listed in the recall notice (83001-83006, 100109, 200003 through 200069, etc.).
Verify your system's serial number against the list provided in the recall notice.
The recalled model is iCT SP Model # 728311.
Images may be labeled incorrectly during cardiac scans, potentially leading to misdiagnosis.
Check your system's serial number against the list of affected numbers provided in the recall notice.
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-2190-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2190-2019 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.
