FDA Medical Device Recalls (openFDA)
Hill-Rom, Inc.: 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.
- Recall number
- Z-0949-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-02-26
- Posted
- 2013-03-14
- Terminated
- 2014-04-16
- Reason
- 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
- 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
- 309
- Distribution
- USA Nationwide Distribution including the state of Canada
- Lot, serial or model codes
- S/N between N230AM1358 & O023AM3687.
- 510(k) numbers
- ["K970636"]
- PMA numbers
- not on file
- Product code
- IOQ
- Firm FEI
- 1824206
- Firm city
- Batesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28