FDA-Device2022-07-27Class II

Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.

Baxter Healthcare Corporation
Hazard

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.

Sold states
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.
Affected count
136 mattresses
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1415-2022

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