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OmniTom/OmniTom Elite- X-ray computed tomography… recallZ-2068-2023 · NeuroLogica Corporation · initiated Jun 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from NeuroLogica Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

NeuroLogica Corporation issued Urgent Medical Device Correction letter to customers via email June 6, 2023. Letter states reason for recall, health risk and action to take: Users may continue to use the NL5000 system with caution, ensuring they are aware of the potential drive issues due to the wheels. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. NeuroLogica will undertake the voluntary corrective action considering the possibility of delay in patient treatment if the scanner is not operational due to battery failure, as well as the potential for the scanner to halt mid scan. The hardware upgrades provide additional safeguards by improving the design to minimize any risks of the above situations from happening. Service engineers will correct all affected devices free of charge and contact you to arrange for the correction starting June 2023. All corrections in the field will be completed by December 31, 2023. Contact customer service team at 1-888-564-8561 (US/Canada) or 978-564-8561 (International) and [email protected].

Recall details

Recall number
Z-2068-2023
Status
Open, Classified
Initiated by the company
Jun 6, 2023
Posted by the FDA
Jul 3, 2023
Recalling firm
NeuroLogica Corporation
Quantity
48 units
Product code
JAK
FDA submissions
K202526, K171183
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.

Product description

OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000

Code information (models, lots, serial numbers)

GTIN: 10815411020335 10815411020663 Serial Numbers: 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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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