CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0 recalled
Fujifilm Healthcare Americas is recalling Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0, distributed nationwide in the US. The recall was initiated on 3 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-1171-2024
- FDA event ID
- 93855
- Recalling firm
- Fujifilm Healthcare Americas, Lexington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jan 2024
- FDA classified
- 21 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jan 2024 | Recall initiated by company | |
| 21 Feb 2024 | Classified by FDA | +49 days |
| 28 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Product as listed by the FDA
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Where it was distributed
US domestic distribution nationwide. International distribution to Israel.
Questions about this recall
Why was it recalled?
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Which lots are affected?
UDI-DI 854904006008 Software versions 7.3.000, 7.2.200, 7.2.100, 7.2.000, 7.1.000, 7.0.000
Where was it sold?
US domestic distribution nationwide. International distribution to Israel.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93855| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Synapse CV with AR recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Other | Nationwide |
More recalls from Fujifilm Healthcare Americas
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 8 states |
| 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 | 30 states |
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