Cuattro LLC recalls software version 4.4.128 due to potential misdiagnosis from showing previous patient images in later studies. Affected units have specific reference and UDI codes.
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Cuattro LLC is recalling its CuattroDR System Software version 4.4.128 because it might show images from earlier patient studies in later ones, leading to incorrect patient diagnoses. This could cause serious errors in medical treatment if not fixed.
The software might display images from a previous patient's study in a new patient's study. This could cause doctors to misdiagnose the correct patient, potentially leading to incorrect treatment decisions.
Medical facilities using the CuattroDR System Software version 4.4.128 are likely affected. Patients receiving imaging studies with this software could be at risk of misdiagnosis.
Check for the software version 4.4.128. Affected units have reference number SWR-00069-MD and unique identifier B269SWR00069MD0.
Verify the software version is 4.4.128 by checking the product details.
The software might show images from a previous patient study in a later study, which could lead to misdiagnosis.
Software version 4.4.128 with reference number SWR-00069-MD and unique identifier B269SWR00069MD0.
Check for the software version 4.4.128 and reference number SWR-00069-MD with unique identifier B269SWR00069MD0.
We’ve drafted a message you can send Cuattro to request your refund or repair — edit it as you like.
Subject: Recall Z-1934-2020 — Cuattro Cuattro Hello, I own a Cuattro that is covered by recall Z-1934-2020 from Cuattro. 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.
