Z-1486-2024Class II

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

Name: Z-1486-2024 Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA...
Creator: Human Care Hc Sweden Ab
Published: 2024-02-23
License: https://open.fda.gov/license/

Human Care HC AB / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process

FDA source

Human Care Hc Sweden Ab began a recall of 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 on 2024-02-23. FDA classified it as Class II and gives the reason as "Patient lift hanger bar may come loose, which could potentially pose risks to patients". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1486-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-23
Posted: 2024-04-05
Recalling firm: Human Care HC AB
Product: 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
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: Patient lift hanger bar may come loose, which could potentially pose risks to patients.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 10
Distribution: US Nationwide distribution in the states of TX, IL, OK, CA.
Product codes and lots: UDI-DI: 7331599999943 Products manufactured between May 2023 and October 2023. Serial Numbers: 236229060002, 236229060005, 236232010015, 236229070004, 236232010006, 236229060003, 236229060009, 236229060006, 236232010005, 236232010003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1486-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1486-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-05

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)