FDA Device recall Z-1411-2022
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01
- FDA Device
- Class II
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01 by Baxter Healthcare, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1411-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-24 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
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.
Identifiers
| code_info | REF P7924A01, UDI 00887761977907; Serial numbers: W218BP4042, W218BP4054, W218BP4056, W218BP4059, W218BP4060, W218BP40…REF P7924A01, UDI 00887761977907; Serial numbers: W218BP4042, W218BP4054, W218BP4056, W218BP4059, W218BP4060, W218BP4061, W218BP4058, W218BP4048, W218BP4069, W218BP4053, W218BP4041, W218BP4043, W218BP4044, W218BP4045, W218BP4046, W218BP4049, W218BP4051, W218BP4052, W218BP4055, W218BP4057, W218BP4062, W218BP4063, W218BP4065, W218BP4066, W218BP4067, W336BP6549, W336BP6550, W336BP6555, W336BP6556, W336BP6557, W336BP6558, W336BP6560, W336BP6561, W336BP6562, W336BP6563, W218BP4050, W336BP6548, W337BP6609, W336BP6541, W336BP6546, W336BP6540, W336BP6542, W336BP6543, and W336BP6544. REF P7924ARENT01, UDI 00887761976863; Serial numbers: W223BP4081, W223BP4084, W242BP4397, W242BP4398, W242BP4401, W242BP4403, W242BP4405, W242BP4407, W242BP4408, W242BP4409, W242BP4410, W231BP4233, W231BP4234, W231BP4241, W231BP4243, W231BP4244, W231BP4248, W231BP4249, W231BP4252, W231BP4253, W235BP4259, W235BP4260, W235BP4265, W235BP4266, W242BP4381, W242BP4387, W242BP4391, W242BP4392, W242BP4393, W242BP4394 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1411-2022%22
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