FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
- Recall number
- Z-0144-2023
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Number P00697902
- Status
- Open, Classified
- Initiated
- 2022-09-30
- Posted
- 2022-10-31
- Terminated
- not on file
- Reason
- Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).
- Root cause
- Device Design
- Action
- Baxter issued an Urgent Medical Device Correction on 09/30/2022. An updated letter was sent on 10/21/2022 to request that users temporarily stop using the WatchCare system. Hillrom, a Baxter company, has received reports of Radio Frequency (RF) interference with other devices near beds that are installed with WatchCare. Specifically, RF interference has been reported with telemetry devices, a bladder scanner, a fetal monitor/doppler, an infusion pump, and a personal use insulin pump. Other third-party medical devices may also be affected. While the system was developed to comply with the most-recent RF standards, it radiates RF that might affect other devices in the vicinity, including devices on both patients and staff members. Given the types of devices that may be affected on both patients and staff, serious harm or death may occur. No serious injuries or deaths reported. Actions to be taken: 1. Immediately locate all affected devices and remove them from clinical care areas (where possible) until the WatchCare functionality is disabled. Affected devices are those Centrella, Progressa and Versacare beds which have WatchCare functionality. Baxter will contact you to arrange for WatchCare to be disabled. Please contact Baxter at 1(800) 445- 3720 or technical.support@hillrom.com for assistance or discuss alternative actions while you wait for the WatchCare feature to be disabled. 2. Be aware that RF emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to, telemetry devices, bladder scanners, fetal monitor/dopplers, infusion pumps, and insulin pumps/blood glucose sensors). Please double-check all unexpected or atypical results and monitor infusions closely. 3. While Baxter continues to work to determine the etiology of this problem and the issue is resolved, use standard, non-RF-based, incontinence management pads. On April 06, 2023, an updated Medical Device Correction letter was sent to customers to infor
- Quantity
- 63 units
- Distribution
- US
- Lot, serial or model codes
- UDI/DI 887761998872, all serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KPN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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