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Class 2 Device Recall OmniTom/OmniTom Elite |
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| Date Initiated by Firm |
June 06, 2023 |
| Date Posted |
July 03, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2068-2023 |
| Recall Event ID |
92506 |
| 510(K)Number |
K171183 K202526
|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product |
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 |
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
|
Recalling Firm/
Manufacturer |
NeuroLogica Corporation
14 Electronics Ave
Danvers MA 01923-1011
|
| For Additional Information Contact |
SAME
978-564-8500
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Manufacturer 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
|
FDA Determined
Cause 2 |
Process design |
| Action |
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 support@neurologica.com. |
| Quantity in Commerce |
48 units |
| Distribution |
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Grand Bahama, India, Italy, Korea, Portugal, Saudi, Scotland, Thailand.
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = NeuroLogica Corporation,
510(K)s with Product Code = JAK and Original Applicant = NeuroLogica Corporation, a subsidiary of Samsung Electronics
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