Philips recalls specific Ingenuity TF PET/CT models due to potential image labeling errors during cardiac scans. Affected units may show incorrect phase tolerance settings in certain cardiac imaging procedures.
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 specific models of their Ingenuity TF PET/CT scanners because they can label images incorrectly during cardiac scans. This could lead to inaccurate medical diagnoses if the error isn't caught.
The system may label images as if phase tolerance was applied when it wasn't, which could cause inaccurate cardiac scan results. This error happens only during specific cardiac step and shoot acquisitions with phase tolerance selected in the imaging process.
Healthcare facilities using the recalled Ingenuity TF PET/CT models with serial numbers from 2003-2006, 2012-2013, 2015 through 2027, and specific model numbers are affected. Medical professionals performing cardiac scans with these systems are most at risk.
Check if your system has model number 882456 and serial numbers from 2003-2006, 2012-2013, 2015 through 2027, or specific model numbers 7550, 7560, 7579, 9219, 9221.
Identify your system's model number and serial number to confirm if it matches the recalled units.
The system may label images incorrectly during cardiac scans when phase tolerance is selected, potentially causing inaccurate results.
The recall record does not specify a remedy, so contact Philips Medical Systems for guidance.
Model # 882456 with serial numbers from 2003-2006, 2012-2013, 2015 through 2027, and specific model numbers 7550, 7560, 7579, 9219, 9221.
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-2193-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2193-2019 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.
