Z-0145-2023Class I

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product...

Name: Z-0145-2023 Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product...
Creator: Baxter Healthcare Corporation
Published: 2022-09-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-09-30 / Open, Classified / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901 on 2022-09-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0145-2023
Classification: Class I
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-10-31
Recalling firm: Baxter Healthcare Corporation
Product: Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901
Product code: KPN Alarm, Conditioned Response Enuresis
Reason for recall: 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 tag: design
FDA 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 [email protected] 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 in commerce: 129 units
Distribution: US
Product codes and lots: UDI/DI 00887761998865, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0145-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0141-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31
Z-0142-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31
Z-0143-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31
Z-0144-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31
Z-0145-2023	Class I	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-31

Product code KPN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)