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Recall Observatory FDA recall evidence

Device product

Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.

Z-1413-2022

June 24, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90511
Status
Ongoing
Classification
Class II
Quantity
8 mattresses
Official record key
device-enforcement:Z-1413-2022

Official wording

Reason: 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.

Code information: UDI 00887761977860, Serial numbers: W214BP3955, W214BP3956, W243BP4436, W243BP4438, W243BP4445, W243BP4446, W243BP4447, and W243BP4448.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.