NeuroLogica recalls all OmniTom NL5000 CT scanners with software version before 05.01.01 due to potential transport issues and system shutdowns that could delay patient treatment.
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
NeuroLogica is recalling all OmniTom NL5000 CT scanners with software versions older than 05.01.01. This recall is needed because these systems might shut down unexpectedly during transport or use, potentially delaying patient treatment if proper procedures aren't followed.
The scanner might shut down unexpectedly during transport or use, which could cause delays in patient treatment if proper usage instructions aren't followed. This issue is related to the operational state of the scanner, not a physical defect.
Healthcare facilities using the OmniTom NL5000 CT scanners with software versions before 05.01.01 are most at risk, as these systems could shut down unexpectedly during transport or use, potentially delaying patient treatment.
Check if your OmniTom NL5000 CT scanner has a software version older than 05.01.01. The serial numbers listed in the recall include 00008 through 00044 (excluding some numbers).
Verify your scanner's software version; if it's older than 05.01.01, it's affected.
Reach out to NeuroLogica Corporation for guidance on next steps.
The recall is due to potential issues with the scanner's operational state, which could cause unexpected shutdowns during transport or use, potentially delaying patient treatment if proper instructions aren't followed.
All OmniTom NL5000 systems with software versions before 05.01.01 are affected.
Check the serial number against the list provided in the recall (00008 through 00044, excluding some numbers) and verify the software version is older than 05.01.01.
We’ve drafted a message you can send NeuroLogica to request your refund or repair — edit it as you like.
Subject: Recall Z-2772-2020 — NeuroLogica NeuroLogica Hello, I own a NeuroLogica that is covered by recall Z-2772-2020 from NeuroLogica. 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.
