Recall Z-1816-2017— Hill-Rom, Inc.

Name: FDA recall Z-1816-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Class II · Terminated

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2017-02-23, terminated 2017-09-19. It names one FDA 510(k) clearance: K962942. 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).. 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..

Recalling firm: Hill-Rom, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Terminated: 2017-09-19
Firm location: Batesville, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K962942 — TOTALCAREHill-Rom, Inc.·cleared 1997-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.