a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P790

FDA device recall Z-0228-2025 · posted 2024-10-25 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.

Action taken

The recalling firm issued letters on and dated 9/18/2024 via first class mail. The letter informed the consignee of the issue, the beds involved, and that Baxter will be upgrading the software on all Centrella Smart+ beds with the affected software version to resolve the issue. An Attachment was enclosed listing the affected product codes for the beds. The hazard involved and the actions to be taken by customers were provided, which included: 1. To mitigate the patient risk associated with this software issue, customers using the Rauland Responder 5 Nurse Call system should ensure the bed exit alert is silenced at the bedside first before silencing the alert at the in-room nurse call wall unit. 2. Please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 3. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.

Root cause

Software design

Status

Open, Classified

Product code

FNL

Quantity affected

2,967 beds

Distribution

Worldwide distribution - US Nationwide. There was government and military distribution. The countries of Canada and Australia.

Date initiated

2024-09-18

Date posted

2024-10-25

Location

Deerfield, IL