Philips recalls specific models of Ingenuity Core CT scanners due to potential image labeling errors during cardiac step and shoot acquisitions. Affected units may produce incorrect phase tolerance labels in scans, requiring correction by medical professionals.
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 models of its Ingenuity Core CT scanners because they can label images incorrectly during cardiac scans. This error might lead to misdiagnosis if not corrected by medical staff.
The scanner may label images as if phase tolerance was applied when it wasn't during cardiac step and shoot acquisitions. This could cause misdiagnosis if the incorrect labeling affects medical interpretation of the scan results.
Healthcare facilities using the recalled Ingenuity Core CT scanners (model #728321) are most at risk. Patients undergoing cardiac scans with these systems could potentially receive incorrect imaging results.
Check for the model number 728321 on the scanner. Affected units have specific system serial numbers listed in the recall notice, including ranges like 10634, 31001, and 52000-52022.
Identify the model number on your scanner; affected units are listed as model #728321 with specific serial number ranges.
The recall is due to a potential error where images may be labeled incorrectly during cardiac step and shoot acquisitions, which could lead to misdiagnosis if not corrected by medical staff.
Check the model number on your scanner; affected units are model #728321 with specific system serial numbers listed in the recall notice.
No, the recall does not require immediate discontinuation. Healthcare facilities should check if their scanner is affected and contact Philips if needed.
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-2188-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-2188-2019 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.
