Health product recall

Centrella Smart+ Bed

Brand(s)
Last updated

Summary

Product
Centrella Smart+ Bed
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100205
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100021
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100020
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100019
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100223
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100224
Centrella Smart+ Bed More than 10 numbers, contact manufacturer. P7900B100231

Issue

Baxter Corporation is issuing an urgent medical device correction for Centrella Smart+ beds with system software version 1.27.000 due to the potential for an interface issue with the Rauland Responder 5 nurse call system. The bed exit system will alert at the bed but may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.

If the bed exit alert fails to notify the caregiver at the assigned remote location (e.g., nurse's station) the staff may be unaware the patient exited the bed if they are unable to hear the local bed alert. As a result, a patient may experience a fall resulting in a critical musculoskeletal injury, including head trauma. To date, Baxter has not received any reports of patient injury related to this issue.

Recall start date: September 19, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Hill-Rom, Inc.
1069 State Route 46 East, Batesville, Indiana, United States, 47006-9167
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77811

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe