TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including
FDA device recall Z-0949-2013 · posted 2013-03-14 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- 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,
- Action taken
- 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
- Root cause
- Software design
- Status
- Terminated
- Product code
- IOQ
- Quantity affected
- 309
- Distribution
- USA Nationwide Distribution including the state of Canada
- Date initiated
- 2013-02-26
- Date posted
- 2013-03-14
- Date terminated
- 2014-04-16
- Location
- Batesville, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (K970636) | Hill-Rom, Inc. | 1997-08-26 |