Philips Medical recalls specific iCT CT scanners due to potential image labeling errors during cardiac scans. Affected models may show incorrect phase tolerance settings in certain 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 Medical is recalling specific iCT CT scanners that may label images incorrectly during cardiac scans. This could lead to misdiagnosis if the images are used for medical decisions.
The system 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 images are used for medical decisions.
Healthcare facilities using the recalled iCT CT scanners are most at risk. Patients receiving scans on these systems may be affected if the images are mislabeled.
Check for the model number 728306 on the scanner. Affected systems have specific serial numbers listed in the recall notice.
Verify the model number on your iCT scanner; affected units have model # 728306.
The recall is due to a potential image labeling error during cardiac step and shoot acquisitions, which could lead to misdiagnosis.
Check for model number 728306 and the specific serial numbers listed in the recall notice.
No, the recall does not require immediate discontinuation; affected facilities should check the model and serial numbers.
We’ve drafted a message you can send Philips Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2189-2019 — Philips Medical Philips Medical Hello, I own a Philips Medical that is covered by recall Z-2189-2019 from Philips Medical. 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.
