Z-1411-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 24, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 mattresses
Product Description
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
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.
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.
Code Information
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.