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High RiskFDAfda-Z-2121-2014SOFTWARE DEFECT

Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, ret...

Units Affected
659
Recall Date
May 5, 2014
Issuing Agency
Hazard
Software Defect

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2121-2014.

The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2121-2014.

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-2121-2014.

Mckesson Medical Immaging

FDA

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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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Mckesson Medical Immaging Recall FAQ

Mckesson Medical Immaging is the subject of a medical devices safety report: Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, ret.... The notice was published on May 5, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 659 units are potentially affected.