| Date Initiated by Firm | August 01, 2018 |
|---|
| Create Date | September 14, 2018 |
|---|
| Recall Status1 |
Terminated 3 on December 13, 2019 |
| Recall Number | Z-2991-2018 |
|---|
| Recall Event ID |
80867 |
| 510(K)Number | K180393 |
|---|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | AIRO Mobile CT System
Model # MobiCT-32 |
|---|
| Code Information |
Model # MobiCT-32 |
| FEI Number |
3010151377
|
Recalling Firm/
Manufacturer |
Mobius Imaging, LLC
2 Shaker Rd Ste F100
Shirley
MA
01464-2535
|
| For Additional Information Contact |
978-796-5068 |
|---|
Manufacturer Reason
for Recall | The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed. |
|---|
FDA Determined
Cause 2 | Radiation Control for Health and Safety Act |
|---|
| Action | Mobius Imaging, LLC sent an URGENT MEDICAL DEVICE RECALL letter to customers advising that a voluntary recall related to the AIRO Mobile CT System was initiated. The letter included the reason for the recall and actions to be taken by the customers. |
|---|
| Quantity in Commerce | 147 |
|---|
| Distribution | US and foreign distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = JAK
|
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