Recall Z-0285-2016— ErgoSafe Products, LLC (DBA) Prism Medical

Name: FDA recall Z-0285-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-08

Class II · Terminated

Class II FDA medical device recall by ErgoSafe Products, LLC (DBA) Prism Medical, initiated 2015-09-08, terminated 2017-05-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.. Reason: Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use.

Recalling firm: ErgoSafe Products, LLC (DBA) Prism Medical
Classification: Class II
Status: Terminated
Initiated: 2015-09-08
Terminated: 2017-05-04
Firm location: Maryland Heights, MO, United States

Product description

Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; weight specification 300 lbs. /136 kg.

Reason for recall

Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling during use

Data sourced from openFDA. This site is unofficial and independent of the FDA.