medical MODERATE Updated 2017-12-20

Elekta Inc recalls Elekta ERGO++ Product Usage: ERGO is often used for ster

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Recalled Product

Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

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Hazard / Issue

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Version 1.7.3 and higher

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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