| Class 2 Device Recall Hitachi Scenaria Wholebody Xray CT System | |
Date Initiated by Firm | October 16, 2019 |
Create Date | November 01, 2019 |
Recall Status1 |
Terminated 3 on April 30, 2020 |
Recall Number | Z-0271-2020 |
Recall Event ID |
84133 |
510(K)Number | K101888 K150595 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Hitachi Scenaria Whole-body X-ray CT System |
Code Information |
Scenaria units S5002-S5014, S5017-S5044 |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087-2371
|
For Additional Information Contact | Aaron J. Pierce 330-425-1313 Ext. 2934 |
Manufacturer Reason for Recall | There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers.
Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and
S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling.
Please contact me if you need further information regarding this report. You can send any questions, comments or requests to recalls@hitachihealthcare.com. |
Quantity in Commerce | 39 |
Distribution | The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR.
The products were distributed to the following foreign countries: Brazil and Mexico. |
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
|
|
|
|