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Hi-Fortune
Kunshan Hi-Fortune Health Products Co.,Ltd · Model HY108 · UDI-DI 06973852591085
10
510(k) clearances
1,469
Adverse events (75 deaths)
23
Recalls
58
Facilities
Description
Weight: 26.6kg, L1005mm*615mm*1270mm HY108 are versatile mobile lifts intended mainly for use in health care, intensive care and rehabilitation. HY108 is excellent aids for daily transfers of adults, bariatrics and children, for instance, lifting to and from wheel chair, bed ,toilet and floor .A Viking equipped with armrests can be used for gait training by patients. Horizontal lifting is also possible with any of the HF stretchers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-25 | Raye's Inc. | Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when |
| 2022-10-24 | Tollos | Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the |
| 2013-01-27 | Prism Medical Services USA | The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars. |
| 2011-04-01 | Invacare Corporation | Component Defect. The rear mast connector on certain patient lifts distributed by the firm, may break. Failure of the rear mast connector, while in use would result in a patient b |
| 2009-04-07 | B.H.M. Medical, Inc. | Premature failure of the stitching at the junction of the shoulder strap and sling body of the BHM/Medi-Man Combi Sling used with patient lifts. |
| 2009-01-19 | Penner Mfg Inc | Incomplete weld on the pillar mounting bracket |
| 2009-01-19 | Penner Mfg Inc | Incomplete weld on the pillar mounting bracket |
| 2009-01-19 | Penner Mfg Inc | Incomplete weld on the pillar mounting bracket |
| 2009-01-19 | Penner Mfg Inc | Incomplete weld on the pillar mounting bracket |
| 2009-01-19 | Penner Mfg Inc | Incomplete weld on the pillar mounting bracket |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.