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Terminated

AC-powered adjustable medical beds with built-in electric DC actuators and controls.

FDA Recall Z-1136-2022 · Posted None

Recalling FirmUmano Medical, Inc.
Recall StatusTerminated
Product CodeFNL
Date Initiated2022-04-11
Date Terminated2024-01-17
Product Quantity355 units

Reason for Recall

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

Firm Action

The firm sent out the recall notification to the consignees on 04/11/2022 via email. The letter instructs the users to avoid using the product and forward the notice to any affected users. The letter directed to the distributors instructs them to stop distribution of the product, send the notice to users of the product, and send a report to the manufacturer conforming inventory and contact information for each site that was contacted.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, PA, AL, GA, AZ, MN, FL, WA, OK, NY, ND, AR, MO, NC, UT, TX, WI, and the countries of Australia, Ireland, and Canada.

Official Source

View FDA Recall →

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

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