CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress recalled
Baxter Healthcare is recalling Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, distributed nationwide in the US. The recall was initiated on 24 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1411-2022
- FDA event ID
- 90511
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 24 Jun 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +26 days |
| 27 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoConnecticutGeorgiaIowaIndianaKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew MexicoNew YorkOhioOklahomaRhode Island
Questions about this recall
Is Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress recalled?
Yes. Baxter Healthcare recalled Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress on 24 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1411-2022.
Why was it recalled?
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.
Which lots are affected?
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, W242BP4395, W242BP4396, W242BP4402, W242BP4404, W243BP4412, W243BP4413, W243BP4414, W243BP4415, W243BP4416, W231BP4213, W231BP4224, W231BP4228, W231BP4229, W231BP4230, W231BP4242, W231BP4245, W231BP4246, W231BP4247, W231BP4250, W231BP4251, W242BP4390, W243BP4418, W243BP4419, W243BP4420, W243BP4421, W243BP4428, W223BP4079, W224BP4102, W224BP4108, W231BP4202, W231BP4203, W231BP4204, W231BP4207, W231BP4209, W231BP4217, W231BP4218, W231BP4220, W231BP4221, W231BP4222, W231BP4223, W231BP4227, W231BP4254, W231BP4255, W231BP4256, W223BP4091, W224BP4103, W231BP4210, W231BP4211, W231BP4214, W231BP4216, W231BP4219, W231BP4257, W235BP4261, W235BP4262, W235BP4263, W235BP4264, W239BP4361, W239BP4365, W239BP4367, W239BP4373, W239BP4375, W242BP4382, W242BP4383, W242BP4385, W242BP4386, W223BP4070, W223BP4071, W223BP4072, W223BP4073, W223BP4074, W223BP4077, W223BP4082, W223BP4083, W223BP4085, W223BP4086, W223BP4087, W223BP4088, W223BP4090, W223BP4092, W223BP4093, W224BP4096, W224BP4098, W224BP4099, W224BP4100, W224BP4101, W224BP4104, W224BP4105, W224BP4109, W224BP4110, W224BP4111, W231BP4205, W231BP4206, W231BP4208, W231BP4212, W231BP4215, W224BP4095, W224BP4097, W224BP4112, W224BP4113, W224BP4114, W224BP4106, W224BP4107, W239BP4364, W239BP4366, W239BP4369, W239BP4371, W239BP4372, W239BP4362, W239BP4368, W239BP4370, W239BP4360, W239BP4363, W239BP4374, W242BP4378, W242BP4379, W242BP4380, W242BP4384, W242BP4399, W242BP4400, W223BP4075, W223BP4080, W223BP4076, W223BP4078, W224BP4094, W224BP4115, and W224BP4116.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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