Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Human Care

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Human Care see related information
Date Initiated by Firm February 23, 2024
Date Posted April 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-1486-2024
Recall Event ID 94140
Product Classification Lift, patient, non-ac-powered - Product Code FSA
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
Code Information UDI-DI: 7331599999943 Products manufactured between May 2023 and October 2023. Serial Numbers: 236229060002, 236229060005, 236232010015, 236229070004, 236232010006, 236229060003, 236229060009, 236229060006, 236232010005, 236232010003
Recalling Firm/
Manufacturer		 Human Care Hc Sweden Ab
Arstaangsvagen 21 B
Stockholm Sweden
Manufacturer Reason
for Recall		 Patient lift hanger bar may come loose, which could potentially pose risks to patients.
FDA Determined
Cause 2		 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 quality@humancaregroup.com In case of recognizing any deviation or irregularity during the fixation control or if in need of additional information email quality@humancaregroup.com
Quantity in Commerce 10
Distribution US Nationwide distribution in the states of TX, IL, OK, CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-