OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim
Summary
The FDA issued a Class II for OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that c by NeuroLogica Corporation. Reason: 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 tr.
Details
Source
Device Recall
External ID
Z-2068-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 48 units
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-06
Company
Danvers, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NeuroLogica Corporation has 8 FDA actions in our database, including 5 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NeuroLogica Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NeuroLogica Corporation have FDA actions?
NeuroLogica Corporation has 8 FDA actions in our database, including 5 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2068-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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