Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
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Brand Name: Leksell Vantage Arc System REF: 1053958. Reason: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.. Classification: Class II. Quantity: 768 (364Left/364Right). Distribution: US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
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