Philips recalls IQon Spectral CT Model #728332 x-ray systems with serial numbers 860004-860043, 860046-860127, 890002 due to potential image labeling errors during cardiac 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 IQon Spectral CT x-ray systems that may label cardiac images incorrectly when using phase tolerance settings. This could lead to inaccurate medical diagnoses if the system mislabels images as having phase tolerance applied when it hasn't been.
When performing cardiac step and shoot acquisitions with phase tolerance selected, the system may incorrectly label images as having phase tolerance applied when it actually hasn't been. This could result in inaccurate medical images that might lead to incorrect diagnoses or treatment decisions.
Healthcare facilities using Philips IQon Spectral CT Model #728332 systems with specific serial numbers are affected. Medical staff performing cardiac scans with phase tolerance settings are most at risk.
Check if your system has the model number 728332 and serial numbers 860004 through 860043, 860046 through 860127, or 890002. This is a computed tomography x-ray system used in medical facilities.
Verify your system's serial number against the listed ranges: 860004-860043, 860046-860127, or 890002.
The recall is for potential image labeling errors during cardiac scans when using phase tolerance settings, which could lead to inaccurate medical images.
Check your system's serial number against the listed ranges to see if it's affected. Philips does not provide a remedy for this recall as the remedy field is null in the official notice.
The recall addresses potential image labeling errors that could affect medical accuracy, but there is no mention of physical injury risks in the official 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-2192-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2192-2019 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.
