CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report
Synapse PACS recalled by FUJIFILM Healthcare Americas
FUJIFILM Healthcare Americas is recalling Synapse PACS, distributed nationwide in the US. The recall was initiated on 10 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1272-2024
- FDA event ID
- 94090
- Recalling firm
- FUJIFILM Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jan 2024
- FDA classified
- 7 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Jan 2024 | Recall initiated by company | |
| 7 Mar 2024 | Classified by FDA | +57 days |
| 13 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Synapse PACS - Version 7.2.200
Where it was distributed
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.
Questions about this recall
Is Synapse PACS recalled?
Yes. FUJIFILM Healthcare Americas recalled Synapse PACS on 10 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1272-2024.
Why was it 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.
Which lots are affected?
Software Version: 7.2.200, UDI: (01)854904006008(10)0702200
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from FUJIFILM Healthcare Americas
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|---|---|---|---|---|---|
| Device | CLASS II | Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas | FUJIFILM Healthcare Americas | Labeling Errors | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | FUJIFILM Healthcare Americas | Other | Nationwide |
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| Device | CLASS II | Asprire Cristalle Mammography System recalled | FUJIFILM Healthcare Americas | Device Malfunction | Nationwide |
| Device | CLASS II | Synapse PACS recalled by FUJIFILM Healthcare Americas | FUJIFILM Healthcare Americas | Device Malfunction | Nationwide |
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