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High RiskFDAfda-Z-1105-2013OTHER

Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR i...

Units Affected
37
Recall Date
October 5, 2012
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1105-2013.

Under certain conditions, when using the Search functionality, the potential exists for the wrong patient's Interactive Documents to display when viewing a signed report in the single patient view. This can occur when the Interactive Document is viewed or auto displayed, dismissed by the user, and then a different patient and signed exam is selected in single patient view. The Notes Viewer will

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1105-2013.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1105-2013.

Siemens Medical Solutions USA, Inc

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Siemens Medical Solutions Usa, Inc Recall FAQ

Siemens Medical Solutions Usa, Inc is the subject of a medical devices safety report: Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR i.... The notice was published on October 5, 2012 by the U.S. Food and Drug Administration (FDA). Approximately 37 units are potentially affected.