Device recall: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with…
Class II FDA enforcement event 90511. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Baxter Healthcare Corporation started this device recall on 24 Jun 2022. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 90511 has 7 product records. The first FDA enforcement report date is 27 Jul 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1411-2022 | Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress. | 200 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1412-2022 | Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. | 404 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1413-2022 | Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. | 8 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1414-2022 | Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. | 202 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1415-2022 | Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. | 136 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1416-2022 | Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. | 70 mattresses | Class II | Ongoing | 27 Jul 2022 |
| Z-1417-2022 | Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. | 9 mattresses | Class II | Ongoing | 27 Jul 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 7Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report Z-1411-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 90511. https://recallregister.com/fda/ii/90511/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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…
- What quantity of product is in FDA event 90511?
- The event has 7 product records. The first record gives this quantity:
200 mattresses
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.