Recall Z-1816-2017 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
| Date | Feb 23, 2017 |
| Status | Terminated |
| Reason | The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period. |
| Root cause | Software change control |
| Action | On 2/23/2017, URGENT: MEDICAL DEVICE CORRECTION 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. Customers without a service contract received the following instructions: Action to be taken by the user: A software update for the TotalCare beds GCI has been released to resolve this issue. Enclosed with this letter are a USB stick with the updated software, instructions on how to update th |
| Quantity | 3037 |
| Distribution | US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962942 | TOTALCARE Hill-Rom, Inc., Feb 3, 1997 |