FUJIFILM Healthcare Americas Corporation recalls Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the…
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…
Read the official notice →- Date
- 2024-02-28
- Country
- United States
- Brand
- FUJIFILM Healthcare Americas
- Product
- 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…
- Classification
- Class II
- Units
- US domestic distribution nationwide. International distribution to Israel.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More FUJIFILM Healthcare Americas recalls
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Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
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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 · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2023-05-03
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Other drugs & medical recalls in the United States
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