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EasyBoost 400
Seneca Devices, Inc. · Model ESB-400H · UDI-DI 00860004936824
10
510(k) clearances
1,482
Adverse events (75 deaths)
23
Recalls
58
Facilities
Description
Air blower unit (with hook) for use with EasyBoost Cushion, for safe working load up to 400 lbs
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.