Z-1268-2024Class II

Synapse PACS - Version 7.1.000

Name: Z-1268-2024 Synapse PACS - Version 7.1.000
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2024-01-10
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2024-01-10 / Open, Classified / root cause: software

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of Synapse PACS - Version 7.1.000 on 2024-01-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1268-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-10
Posted: 2024-03-07
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse PACS - Version 7.1.000
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 22 units (22 OUS)
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 codes and lots: Software Version: 7.1.000; UDI: (01)854904006008(10)0701000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1268-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1268-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07
Z-1269-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07
Z-1270-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07
Z-1271-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07
Z-1272-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07
Z-1273-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-13	2024-03-07

Product code LLZ

K190232Class IISynapse PACSFujifilm Corporation / cleared 2019-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)