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SIZEWISE RENTALS, L.L.C. · Model 47060255 · UDI-DI 00845699005482
10
510(k) clearances
928
Adverse events (251 deaths)
7
Recalls
223
Facilities
Description
Low Profile BHB Platform Bed with Restraints and Enclosed Bottom (35" x 82") - Cocoa
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-21 | Oakworks Inc | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs. |
| 2010-02-26 | Stryker Medical Div. of Stryker Corporation | The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The sc |
| 2010-02-26 | Stryker Medical Div. of Stryker Corporation | The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The s |
| 2010-02-26 | Stryker Medical Div. of Stryker Corporation | The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The sc |
| 2009-09-16 | Hill-Rom, Inc. | The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. |
| 2009-09-16 | Hill-Rom, Inc. | The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. |
| 2005-11-16 | Sunrise Medical CCG, Inc. | Malfunction- the Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional . |
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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.