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Bed, Manual

FDA product code FNJ · Class 1 · General Hospital

331
Registered devices
928
Adverse events
7
Recalls
39
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-04-21Oakworks IncThe warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
2010-02-26Stryker Medical Div. of Stryker CorporationThe 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 th
2010-02-26Stryker Medical Div. of Stryker CorporationThe 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 t
2010-02-26Stryker Medical Div. of Stryker CorporationThe 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 th
2009-09-16Hill-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 o
2009-09-16Hill-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 o
2005-11-16Sunrise 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-func

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.