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High RiskFDAfda-Z-0651-2014SOFTWARE DEFECT

The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, includin...

Units Affected
58
Recall Date
September 20, 2013
Issuing Agency
Hazard
Software Defect

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0651-2014.

An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop").

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0651-2014.

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 Midmark Corp Dba Progeny Inc 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-0651-2014.

Midmark Corp dba Progeny Inc

FDA

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Midmark Corp Dba Progeny Inc Recall FAQ

Midmark Corp Dba Progeny Inc is the subject of a medical implants safety report: The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, includin.... The notice was published on September 20, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 58 units are potentially affected.