Z-0949-2013Class II

TotalCare SpO2RT2 bed

Name: Z-0949-2013 TotalCare SpO2RT2 bed
Creator: Hill-Rom, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2013-02-26 / Terminated / root cause: software

FDA source

Hill-Rom, Inc. began a recall of TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care... on 2013-02-26. FDA classified it as Class II and gives the reason as "In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the...". 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-0949-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-03-14
Terminated: 2014-04-16
Recalling firm: Hill-Rom Inc.
Product: TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Product code: IOQ Bed, Flotation Therapy, Powered
Reason for recall: In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,
Root cause tag: software
FDA root cause: Software design
Action: Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720
Quantity in commerce: 309
Distribution: USA Nationwide Distribution including the state of Canada
Product codes and lots: S/N between N230AM1358 & O023AM3687.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0949-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0949-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-14

Product code IOQ

K970636Class IITotalcare., Modular Therapy System (Mts)Hill-Rom, Inc. / cleared 1997-08-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)