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High RiskFDAfda-Z-0982-2014OTHER

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

Units Affected
178,711
Recall Date
November 27, 2013
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0982-2014.

GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network¿. 4.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0982-2014.

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-0982-2014.

GE Healthcare, LLC

FDA

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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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Ge Healthcare, Llc Recall FAQ

Ge Healthcare, Llc is the subject of a medical devices safety report: GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.. The notice was published on November 27, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 178,711 units are potentially affected.