Allen—Bow Frames: May Crack during Use
November 15, 2017 | Strategic Insights for Health System
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In an Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, Allen states that the above frames may crack during use, potentially resulting in critical harm to the patient. Allen also states that it has received one report of this problem occurring in the field and no reports of patient injury associated with this problem. The manufacturer has not confirmed the...