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Synapse PACS - Version 7.2.100 recallZ-1271-2024 · FUJIFILM Healthcare Americas Corporation · initiated Jan 10, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

FDA root cause category: Software design

What the company is doing

URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers January 26, 2024. In an abundance of caution, FUJIFILM is recommending that customer/end users take one of the following actions until the correction is applied: 1. To not perform measurements on Secondary Capture Images that are displayed together with Breast Tomo Images. 2. Ensure Secondary Capture Image has valid pixel spacing values using the DICOM Header Tool. Please 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. Please contact our field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at [email protected], if you have any further questions regarding this field action. Please keep a copy of this letter with your instructions for use.

Recall details

Recall number
Z-1271-2024
Status
Open, Classified
Initiated by the company
Jan 10, 2024
Posted by the FDA
Mar 7, 2024
Recalling firm
FUJIFILM Healthcare Americas Corporation
Quantity
35 Units (28 US, 7 OUS)
Product code
LLZ
FDA submissions
K190232
Distribution
Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.

Product description

Synapse PACS - Version 7.2.100

Code information (models, lots, serial numbers)

Software Version: 7.2.100, UDI: (01)854904006008(10)0702100

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94090).

Sources and updates

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