Date Initiated by Firm | July 31, 2019 |
Create Date | August 28, 2019 |
Recall Status1 |
Terminated 3 on December 02, 2020 |
Recall Number | Z-2400-2019 |
Recall Event ID |
83556 |
510(K)Number | K173632 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | SOMATOM go.Up;
Models #11061620
Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data |
Code Information |
Serial Number 111232 111409 111332 111370 111371 111383 111378 111352 111299 111273 111373 111289 111339 111317 111333 111297 111237 111303 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact | Rebecca Tudor 610-219-4834 |
Manufacturer Reason for Recall | The injector holder could potentially fall off together with the injector and the storage box. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 1. Take special care when rotating the injector and storage box horizontally
2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm.
3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved
intermediate version free of charge.
4. Please ensure all users of the affected products are aware.
5. Retain this notification in your product related records and place a copy in the medical device's instructions for use.
6. If you have distributed this product, identify your customers and notify them.
If you wish to request an earlier appointment or have additional questions, feel free to contact service organization at 1-800-888-7436 . |
Quantity in Commerce | 18 units |
Distribution | US Nationwide Distribution in the states
FL
KS
WI
NE
MS
OH
TX
NY
LA
IN
IL
OK
MI
GA
NJ
AK
CT
AL
MD |
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.
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510(K) Database | 510(K)s with Product Code = JAK
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