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High RiskFDAfda-Z-2500-2018OTHER

Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and mini...

Units Affected
459
Recall Date
June 11, 2018
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2500-2018.

The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2500-2018.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Philips Healthcare or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2500-2018.

Philips Healthcare

FDA

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Philips Healthcare Recall FAQ

Philips Healthcare is the subject of a medical implants safety report: Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and mini.... The notice was published on June 11, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 459 units are potentially affected.