NeuroLogica recalls OmniTom Elite X-ray devices due to potential wheel loosening causing treatment delays and batteries with contaminated boards that may prevent device operation.
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
NeuroLogica is recalling OmniTom and OmniTom Elite X-ray devices because wheels can loosen over time, risking delays in patient treatment. Batteries in these devices may contain contaminated boards that could prevent the device from powering on, also causing treatment delays.
Wheels on the device can loosen over time, making it difficult to operate properly and potentially delaying patient treatment. Batteries used in the NL5000 device contain contaminated boards that may prevent the device from powering on, which could also delay patient treatment.
Healthcare facilities using NeuroLogica's OmniTom or OmniTom Elite X-ray devices for head and neck imaging are most at risk. Patients receiving treatment with these devices could experience delays if the equipment malfunctions.
Check for model number NL5000 with GTINs 10815411020335 or 10815411020663. Serial numbers start with 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R.
Verify your device has model number NL5000 with GTINs 10815411020335 or 10815411020663.
Ensure the wheels are securely fastened to prevent loosening that could delay patient treatment.
Confirm the device powers on to avoid issues with contaminated battery boards causing treatment delays.
NeuroLogica recalls OmniTom and OmniTom Elite X-ray devices because wheels can loosen over time, potentially delaying patient treatment. Batteries in these devices may contain contaminated boards that could prevent the device from powering on, also causing treatment delays.
The affected model is NL5000 with GTINs 10815411020335 and 10815411020663.
Check for model number NL5000 with the specified GTINs and serial numbers starting with 10 14 23 25 26 36 38 40 41 42 44 46 48 49 50 51 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 15R.
We’ve drafted a message you can send NeuroLogica to request your refund or repair — edit it as you like.
Subject: Recall Z-2068-2023 — NeuroLogica NeuroLogica Hello, I own a NeuroLogica that is covered by recall Z-2068-2023 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.