Recall Z-1352-2012 ยท FNL Bed, Ac-Powered Adjustable Hospital
Stryker Medical Division of Stryker Corporation
Stryker Epic Critical Care Bed (Model 2030), Stryker, Portage, MI 49002 Product Usage: EPIC II (model 2030) Critical Care beds Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in
| Date | Mar 30, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int |
| Root cause | Component change control |
| Action | Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake com |
| Quantity | 4060 |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.