FDA-Device2012-11-14Class II

AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

Primus Medical LLC
Hazard

The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse.

Sold states
Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.
Affected count
342 Beds
Manufactured in
8401 Southern Blvd, N/A, Boardman, OH, United States
Products
AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2013

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