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High RiskFDAfda-Z-1932-2020ELECTRICAL SHOCK

Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...

Units Affected
25
Recall Date
April 10, 2020
Issuing Agency
Hazard
Electrical Shock

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1932-2020.

When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1932-2020.

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-1932-2020.

Philips North America, LLC

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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Philips North America, Llc Recall FAQ

Philips North America, Llc is the subject of a surgical devices safety report: Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnost.... The notice was published on April 10, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 25 units are potentially affected.