AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, O

FDA device recall Z-0270-2013 · posted 2012-11-08 · Terminated

Recall details

Recalling firm

Primus Medical LLC

Reason for recall

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.

Action taken

The firm, Primus Medical LLC, sent an "Important Notification Relating to Primus Medical Product TL500" letter dated March 29, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to replace the "Retaining washers & Clevis Pins" with the "Clevis Pins & Bow Tie Cotter Pins" in the TL500-001 Service Pack provided with the letter in order to avoid any potential failure and/or bed collapse and to return the" Retaining washers & Clevis Pins" after the replacement procedure is performed. If you have any questions, or need assistance in performing the replacement, call 330-965-9681.

Root cause

Equipment maintenance

Status

Terminated

Product code

FNL

Quantity affected

342 Beds

Distribution

Nationwide distribution: USA including states of: AZ, IL, KY, MD, MI, OH, OR, PA, TX and VA.

Date initiated

2011-02-02

Date posted

2012-11-08

Date terminated

2014-05-14

Location

Boardman, OH