Philips recalls specific Ingenuity CT x-ray systems (model 728326) due to potential cardiac imaging errors when phase tolerance settings are misconfigured during 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 Ingenuity CT x-ray systems (model 728326) because they may produce incorrect cardiac images when specific phase tolerance settings are used during scans. This could lead to misdiagnosis if the images are interpreted incorrectly.
The system may label images as if phase tolerance was applied when it wasn't, which could cause incorrect cardiac imaging results. This might lead to misdiagnosis if the images are interpreted without proper context.
Healthcare facilities using the recalled Ingenuity CT systems are affected. Medical professionals performing cardiac scans with the specific model numbers are most at risk of potential misdiagnosis.
Check for the model number 728326 on the system. The system serial numbers range from 10474 to 300154 and include specific numbers like 30003 through 30009, 30011 through 30015, and others listed in the recall notice.
Identify the model number on the system, which should be 728326 for affected units.
Reach out to Philips Medical Systems for guidance on next steps if the system is affected.
The model number is 728326.
System serial numbers range from 10474 to 300154, including specific numbers like 30003 through 30009, 30011 through 30015, and others listed in the recall notice.
The error may cause cardiac images to be mislabeled as if phase tolerance was applied when it wasn't, potentially leading to misdiagnosis if the images are interpreted incorrectly.
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-2186-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2186-2019 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.
