Z-1816-2017Class II

TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and...

Name: Z-1816-2017 TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and...
Creator: Hill-Rom, Inc.
Published: 2017-02-23
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2017-02-23 / Terminated / root cause: software

FDA source

Hill-Rom, Inc. began a recall of TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A) on 2017-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1816-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Posted: 2017-04-12
Terminated: 2017-09-19
Recalling firm: Hill-Rom Inc.
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).
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: software
FDA 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 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
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1816-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1816-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

Product code FNL

K962942Class IITotalcareHill-Rom, Inc. / cleared 1997-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)