FDA Recall Open, Classified

Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

Recall: Z-1486-2024 · Initiated February 23, 2024

Recall

Recall Number
Z-1486-2024
Event Number
94140
Firm
Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden
FEI Number
3006291016
Product Code
FSA
Status
Open, Classified
Root Cause
Process control
Initiated
February 23, 2024
Posted
April 5, 2024

Description

Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

Reason

Patient lift hanger bar may come loose, which could potentially pose risks to patients.

Action

On 2/23/24, Field Safety Notices were emailed to customers who were asked to do the following: 1) Checking the fixation by carefully pulling on the shaft. Should you observe any deviation or irregularity, please inform us promptly. 2) Read and understand this letter and provide a confirmation via email to the address [email protected] In case of recognizing any deviation or irregularity during the fixation control or if in need of additional information email [email protected] On 5/6/24, Field Safety Notices were emailed to customers with additional instructions for distributors and dealers to distribute the notice to all customers who have purchased the impacted products.

Distribution

US Nationwide distribution in the states of TX, IL, OK, CA.

Quantity

10