Recall Z-1176-2016 ยท FNL Bed, Ac-Powered Adjustable Hospital
CHG Hospital Beds Inc
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard feature
| Date | Mar 15, 2016 (initiated Feb 18, 2015) |
| Status | Terminated |
| Reason | It was identified that in some situations the bed exit alarm may not function as intended. The software code for the bed exit system has the potential to auto-reset erroneously. In some situations, the software code does not allow enough time for the weight value to fall to zero once the patient egresses from the bed, in which case, the bed has the potential to reset the bed exit alarm even without a patient on the bed. The bed exit on the Spirit Select bed may incorrectly reset if the Auto Reset option is selected. A patient fall may result in soft tissue or bone injury which may require med |
| Root cause | Software design |
| Action | On 2/18/2016, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions or concerns, please contact Stryker Customer Service (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-6 p.m. (EST). |
| Quantity | 1892 |
| Distribution | Distributed US (nationwide) and in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.