| Date Initiated by Firm | April 30, 2021 |
|---|
| Create Date | June 02, 2021 |
|---|
| Recall Status1 |
Terminated 3 on July 29, 2024 |
| Recall Number | Z-1775-2021 |
|---|
| Recall Event ID |
87938 |
| 510(K)Number | K151859 |
|---|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | Synapse Cardiovascular (Synapse CV).
Software Versions: 6.0 to 6.2.1
The Synapse Cardiovascular image is a management and reporting system |
|---|
| Code Information |
Software Versions: 6.0 to 6.2.1 |
Recalling Firm/
Manufacturer |
Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
|
| For Additional Information Contact | SAME
617-861-5300 |
|---|
Manufacturer Reason
for Recall | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | Fujifilm issue consignee notifications via email on April 30, 2021. Letter states reason for recall, health risk and action to take:
ACTIONS TO BE TAKEN BY CUSTOMER/END USER
FUJIFILM will offer an upgrade to Synapse CV 6.2.2 to resolve this issue. FUJIFILM recommends the following actions:
1) Complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.
2) Contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a ticket for the upgrade.
Until your upgrade is scheduled and completed, Advanced Reporting users can continue to safely use Synapse CV by choosing one of the following options:
1) Merge the older patient record to the newer patient record, and then delete the older patient record. This sequence retains the most recent internal patient database ID and deletes an older internal patient database ID that will not be erroneously reassigned.
2) Merge the newer patient record to the older patient record only after additional new patients have been added beyond the record you want to merge. This sequence ensures that the most recent internal patient database ID is assigned to a record that is not involved in the merge activity.
3) Always check patient information presented in the report with other information provided for that patient/study.
Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action. |
|---|
| Quantity in Commerce | 44 US and 4 OUS |
|---|
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center. |
|---|
| 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 = LLZ
|
|---|
