| Date Initiated by Firm | November 29, 2018 |
|---|
| Create Date | February 23, 2019 |
|---|
| Recall Status1 |
Terminated 3 on May 07, 2020 |
| Recall Number | Z-0936-2019 |
|---|
| Recall Event ID |
81959 |
| 510(K)Number | K150493 |
|---|
| Product Classification |
Computer, diagnostic, programmable - Product Code DQK
|
| Product | Sensis Vibe System, Model Number 11007642, with software version VD10B. |
|---|
| Code Information |
Serial Number 120019 |
| FEI Number |
2240869
|
Recalling Firm/
Manufacturer |
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
|
| For Additional Information Contact | Anastasia Sokolova
610-219-4834 |
|---|
Manufacturer Reason
for Recall | A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Urgent Medical Device Correction letters were sent to customers on 11/29/18. |
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| Quantity in Commerce | 1 |
|---|
| Distribution | The products were distributed to the following US states: NJ. |
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| 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 = DQK
|
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