| Date Initiated by Firm | September 11, 2020 |
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| Create Date | October 22, 2020 |
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| Recall Status1 |
Terminated 3 on November 17, 2021 |
| Recall Number | Z-0282-2021 |
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| Recall Event ID |
86494 |
| 510(K)Number | K190232 |
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| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. |
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| Code Information |
Synapse Software Version 5.6.1 |
| FEI Number |
1000513161
|
Recalling Firm/
Manufacturer |
Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
|
| For Additional Information Contact | Jeffrey Wan
201-675-8947 |
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Manufacturer Reason
for Recall | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
|
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FDA Determined
Cause 2 | Software change control |
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| Action | Letter was sent to all affected customers on 09/11/2020 stating the following: FUJIFILM will offer an upgrade to Synapse PACS 7.1.100 to resolve this issue. Synapse PACS 7.1.100 is estimated to be available by the end of September.
Until the patch is available, users can continue to safely use Synapse PACS by following these additional instructions:
1. Ensure that the 3D Sphere MAX value is within the spheres range. If the 3D Sphere MAX value is observed to be much higher than expected, the value should not be used when rendering a clinical decision until the issue is corrected.
Customers should complete and return the Field Action Verification Form attached to the recall letter. |
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| Quantity in Commerce | 1 |
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| Distribution | US Nationwide distribution including in the state of Minnesota. |
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| Total Product Life Cycle | TPLC Device Report |
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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 = LLZ
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