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Terminated

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

FDA Recall Z-0285-2016 · Posted 2015-11-17

Recall StatusTerminated
Product CodeFSA
Date Initiated2015-09-08
Date Terminated2017-05-04
Product Quantity1,721 lifts

Reason for Recall

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

Firm Action

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 [email protected] 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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