Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674,

FDA device recall Z-2656-2014 · posted 2014-09-16 · Terminated

Recall details

Recalling firm

GF Health Products, Inc./d.b.a.Basic American Metal Products

Reason for recall

The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended.

Action taken

Consignees were sent a Basic American Medical Products "Product Field Correction Notice" dated July 21, 2014. The letter provided the background information on the recall and the " Required Action" to be taken which includes the replacement of the head deck. Consignees need to contact 1-888-974-4347 to scheduled the replacement order. The replaced head decks should be disposed and disposal documented on the enclosed Letter of Disposal Agreement. The completed letter needs to be returned to Basic American Medical Products. For additional questions they can contact the Field Correction Coordinator at 1-888-974-4347 or electronically: fieldcorrection@grahamfield.com.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FNL

Quantity affected

1941

Distribution

Worldwide Distribution: USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA,MI, MN, MS, MO,MT, NE, NH, NJ, NM, NY,M NC, ND, OH, OK, OR, PA, RI, SC,

Date initiated

2014-07-21

Date posted

2014-09-16

Date terminated

2015-08-11

Location

Fond Du Lac, WI