Class 2 Device Recall TotalCare

• Date Initiated by Firm: February 23, 2017
• Create Date: April 12, 2017
• Recall Status: Terminated on September 19, 2017
• Recall Number: Z-1816-2017
• Recall Event ID: 76506
• 510(K)Number: K962942
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
• Code Information: P1900 SN: K328AM6065 to Q245AM0691 PR1900 SN: L082AL7316 to R343AL4516 U1900 SN: L257AM0541 to O311AM7169 Scale Upgrade Kit P1957A produced after March 13, 2013 (not serialized).
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 1069 State Road 46 E; Batesville IN 47006-7520
• For Additional Information Contact: Hill-Rom Technical Support ; 800-445-3720
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 the GCI software, and a response form to be returned within 30 days. 1) Identify any affected TotalCare¿ beds with 3-Level Patient Position Monitoring in your facility by using the criteria above. 2) Please use the enclosed instructions and update the software on each potentially affected TotalCare¿ bed immediately. 3) Record the serial numbers of the beds being updated on the response form and return to Hill-Rom within 30 days of receipt of this letter. Additional USB sticks with the updated software may be obtained by contacting Technical Support at 1-800-445-3720 (select Option 2, then Option 2 again). Until each of the affected TotalCare¿ beds are updated with the new software, we recommend you do one or more of the below to avoid any potential occurrences of bed exit not functioning. 1. Power cycle (unplug and plug in the bed mains power cord) once every 48 hours. 2. Remove the Patient and re-zero the scale once every 48 hours. 3. Turn off and do not use the Bed Exit Alarm functionality. Continued use of the bed exit alarm without the mitigations listed above may cause risk to patient. If you have an upgrade kit (P1957A) that has not been installed, please contact Hill-Rom for return and replacement. Customers with a service contract received the following instructions: Action to be taken by the user: A Hill-Rom representative per
• Quantity in Commerce: 3037
• Distribution: US Nationwide. AUSTRALIA BANGLADESH BRAZIL CANADA CHINA GERMANY INDIA ITALY KUWAIT PAKISTAN SAUDI ARABIA THAILAND UNITED ARAB EMIRATES CYPRUS GREECE NETHERLANDS
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FNL and Original Applicant = HILL-ROM, INC.