medical MODERATE Updated 2017-08-16

Elekta, Inc. recalls iGUIDE Software 2.2 Product Usage: Control of accurate

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Recalled Product

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

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Hazard / Issue

Incorrect PEC values.

Issued by

FDA

Affected States: AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA
Lot/Code Info: Scope; iGUIDE 2.2.0, iGUIDE 2.2.1

✅ 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.

Looking for a safe alternative?

Search Amazon for iGUIDE Software 2.2 →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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