FDA-Device2024-04-10Class II
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Baxter Healthcare Corporation
Hazard
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as potentially impacted by these service inconsistencies and therefore, Baxter will need to reassess the impacted mattresses to confirm they have been corrected as identified by the service order, and to confirm the correct serial numbers have been identified.
Sold states
US Nationwide distribution in the state of Colorado.
Affected count
232 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1400-2024Don't want to check this manually?
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