Recall Z-2122-2014 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
| Date | Jul 28, 2014 (initiated Jun 4, 2014) |
| Status | Terminated |
| Reason | Stryker has received complaints from the field alleging instances where the In Touch beds are hoisted or lifted from the floor and the casters have fallen off. The investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. If more than one caster on a unit is damaged, brake functions can be affec |
| Root cause | Device Design |
| Action | On 06/30/1014 the firm sent "Urgent Medical Device Notification" letters to their customers. |
| Quantity | 11,632 units |
| Distribution | Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Bra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.