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High RiskFDAfda-Z-2709-2014OTHER

Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provi...

Units Affected
364
Recall Date
December 27, 2005
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2709-2014.

The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2709-2014.

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-2709-2014.

Philips Medical Systems (Cleveland) Inc

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 Medical Systems (cleveland) Inc Recall FAQ

Philips Medical Systems (cleveland) Inc is the subject of a medical devices safety report: Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provi.... The notice was published on December 27, 2005 by the U.S. Food and Drug Administration (FDA). Approximately 364 units are potentially affected.