Philips—MultiDiagnost Eleva Systems: ​Upper and Lower Tilt Actuator Fixation May Break

April 11, 2018 | Risk Management News

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​ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a March 23, 2018, Urgent Field Safety Notice letter submitted by an ECRI Institute member hospital, Philips states that the fixation of the upper and lower tilt actuator of the above systems may break off, causing the table to rotate from 0 to +90/-90 degrees at a high speed, potentially causing the patient to fall off the table. Philips also states that this rotating movement cannot be stopped by the user. Philips further states that uncontrolled rotation poses a risk of injury for the patient, user, or bystanders standing in the vicinity of the system, potentially leading to injury that necessitates medical intervention. The manufacturer has not confirmed the...

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