pro+ recallZ-1417-2022 · Baxter Healthcare Corporation · initiated Jun 24, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued a Medical Device Correction Letter dated 6/24/2022 via UPS on 6/24/2022. The letter described the problem, the potential risk, and the actions to be taken by the user. The actions were to inspect their product and check for any indication of error codes present. Identification of error codes were described depending on the configuration of the consignee's product. If the consignee detects an error code, they are to contact the Hillrom Technical Support to have the PRO+ Surface corrected. A list of affected serial numbers was attached to the letter as Appendix 1. Distributors were instructed to share the notification with their end users. A response form was attached to be completed and returned within 2 weeks to confirm they have reviewed and understand the attached letter and that distributors have shared the notification with their end users and will complete the field action
Recall details
- Recall number
- Z-1417-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9 mattresses
- Product code
- IOQ
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NM, NM, NY, OH, OK, RI, SD, TN, TX, VT, and WI. There was government distribution but no military distribution. The country of Canada.
Product description
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Code information (models, lots, serial numbers)
UDI 00887761977914; Serial numbers: W238BP4349, W238BP4350, W238BP4352, W238BP4354, W238BP4355, W238BP4356, W238BP4357, W238BP4358, and W238BP4359.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- pro+ P7923A04Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90511).
- Z-1411-2022 · Open, ClassifiedHill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
- Z-1412-2022 · Open, ClassifiedHill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.
- Z-1413-2022 · Open, ClassifiedHill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
- Z-1414-2022 · Open, ClassifiedHill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.
- Z-1415-2022 · Open, ClassifiedHill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.
- Z-1416-2022 · Open, ClassifiedHill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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