Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053R, and 330057; weight specification 300 lbs

FDA device recall Z-0284-2016 · posted 2015-11-17 · Terminated

Recall details

Recalling firm

ErgoSafe Products, LLC (DBA) Prism Medical

Reason for recall

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

Action taken

The firm, Prism Medical, sent a "Field Safety Notice (FSN 0008)" letter dated 9/8/2015 to all consignees by email via their sales portal. The letter describes the product, problem and actions to be taken. The consignees were instructed to call Prism Medical directly at 1-314-219-8655 and indicate that you are participating in the 300 series lift recall; provide your existing 300 series lift model number and serial number; follow the instructions provided; complete and return the Acknowledgement Form via scanned & signed to bschoenman@prismmedicalltd.com or fax to: 314-692-7858, Attention: 300 series recall. For further information please contact: Prism Medical Quality department at: 1-314-219-8655 or North American Director for Quality & Regulatory Affairs at 1-314-219-8614.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

561 lifts

Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, South Korea, Taiwan, Mexico, Japan, and Great Britain.

Date initiated

2015-09-08

Date posted

2015-11-17

Date terminated

2017-05-04

Location

Maryland Heights, MO