Recall Z-2656-2014 ยท FNL Bed, Ac-Powered Adjustable Hospital
GF Health Products, Inc./d.b.a.Basic American Metal Products
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.).
| Date | Sep 16, 2014 (initiated Jul 21, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 Coordi |
| Quantity | 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, SD, TN, TX, LT, VA, WA, WV, and WI and PUERTO RICO and the country of CANADA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.